U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
A defective electrical component in the battery charging circuit in two lots of the probp 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. this potential defect resides with the device, not the battery. the over-voltage condition can result in high nimh battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components.
Acción
Welch Allyn sent an Urgent Medical Device Recall letter and Response Forms dated February 21, 2017. They were mailed to the first round of customers beginning on Monday February 27, 2017, via US Postal Service Priority Mail. Welch Allyn will follow up with second round of mailings to the additionally identified end users the week of March 20, 2017.
All end users will be instructed to confirm that their unit is affected; and if affected, a replacement unit will be provided so that the affected unit can be returned and scrapped. --- Of the 1120 units, a total of 981 units were distributed from Welch Allyn warehouses and 139 units remained under Welch Allyn control and were not distributed. These units have since been destroyed.
For further questions, please call (844) 360-8220.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Pin, fixation, smooth - Product Code HTY
Causa
Mislabeling on three lots of k-wires. the incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355ns (lot 61005), 1600-9625ns (lot 60297), and 1604-162ns (lot 62856).
Acción
The firm will mail recall letters to the customers who received the mislabeled k-wires on February 21, 2017. Letters will be sent by UPS to expedite the delivery.
The firm will contact the non-responding accounts at least two more times.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Guide wires sized as .045 x 6 were mis-packaged as .054 x 7 guide wires and those sized as .054 x 7 were mis- packaged as .045 x 6 guide wires. there is a possibility that using the incorrect guide wire size can cause health hazards, such as mal or nonunion, need for revision surgery, and histological response (if wire breaks).
Acción
Acumed sent an Urgent Medical Device Recall letter dated 02/16/2017, to all affected customers on 02/17/2017.
Consignees were instructed to follow special instructions and send survey to RecallNotification@acumed.net.
Domestic customers with questions or need to return products to Acumed, please contact Acumed Agent Inventory via email AgentInventory@acumed.net to obtain a Return Material Authorization (RMA) number or contact your agent directly.
International customers with questions or need to return products to Acumed, please contact Acumed Business Service via email at BusinessServices@acumed.net or call to obtain a Return Material Authorization (RMA) number.
Customers with questions about recall can call 877-627-9957, choose Option 4 (US and Canada), or call 001-503-627-9957, choose option 4 (outside of US and Canada).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Causa
Oec flexiview 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
Acción
On February 21, 2017, an Urgent Medical Device Correction letter was sent to one consignee with an affected unit; a field service representative hand delivered the customer communication.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Pump, infusion - Product Code FRN
Causa
On 2/24/2016 during post sterilization inspection of part number f180 precision flow rate tubing, lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for part number #317036 5 x 6.5 st bag combo. the firm decided to recall precision flow rate tubing and rms high-flo subcutaneous safety needles sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. the firm determined that the issue was large than just the one lot and recalled the product via march 10, 2016 voluntary medical device corrections and removal notification to customers. the recall was conducted without fda notification.
Acción
On March 10, 2016 RMS Medical Products distributed Urgent Voluntary Medical Device Corrections and Removal notices to their customers. On March 12, 2016 & on March 18, 2016, RMS Medical Products distributed a 2nd Urgent Voluntary Medical Device Corrections and Removal notices to their customers advising them that affected products list was reduced after a comprehensive risk assessment was performed. Customers are advised to check stock, quarantine, cease distribution and remove product from use. If customers further distributed product, they are also encouraged to inform the affected parties. Customers are encouraged to complete and return the acknowledgement form via fax to: 845-469-5518.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
On 2/24/2016 during post sterilization inspection of part number f180 precision flow rate tubing, lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for part number #317036 5 x 6.5 st bag combo. the firm decided to recall precision flow rate tubing and rms high-flo subcutaneous safety needles sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. the firm determined that the issue was large than just the one lot and recalled the product via march 10, 2016 voluntary medical device corrections and removal notification to customers. the recall was conducted without fda notification.
Acción
On March 10, 2016 RMS Medical Products distributed Urgent Voluntary Medical Device Corrections and Removal notices to their customers. On March 12, 2016 & on March 18, 2016, RMS Medical Products distributed a 2nd Urgent Voluntary Medical Device Corrections and Removal notices to their customers advising them that affected products list was reduced after a comprehensive risk assessment was performed. Customers are advised to check stock, quarantine, cease distribution and remove product from use. If customers further distributed product, they are also encouraged to inform the affected parties. Customers are encouraged to complete and return the acknowledgement form via fax to: 845-469-5518.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Causa
Navilyst medical, inc. (nmi) the manufacturer of the xcela picc with pasv, bioflo picc with pasv and the bioflo picc, conducted this recall to the end user level based on information received from greatbatch medical, the manufacturer of the viapeel ptfe peelable introducer. greatbatch medical determined that the products listed in their 11/11/2016 recall notification have the potential for the handles to detach from the sheath during use. nmi has confirmed that the affected sheaths, greatbatch model number 10890-006, had been included in packaged xcela and bioflo picc kits.
Acción
The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to
1. IMMEDIATELY
o Stop using the product subject to recall.
o Remove any affected (recalled) product from your inventory (whether in labs,
Central Supply, Shipping and Receiving or ANY other location).
o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics Company)
o Forward a copy of this recall notification to all sites to which you have distributed affected product.
2. Complete and return the Reply Verification Tracking Form.
o If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
o Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form.
o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com
o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator
Fax number 1-800-782-1357
3. Package and Return the Recalled Product to: AngioDynamics, Inc.
603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator.
If you have any questions, please call: 518-795-1358 or 518-795-1116.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Purewick is recalling external catheter for women wicks because the labeling did not contain the phrase "this product contains dry natural rubber" and/or erroneously included the phrase "latex-free." the white gauze component of the purewick contains dry natural rubber.
Acción
A Urgent Medical Device recall letter dated March 2, 2017 will be sent to customers to inform them that PureWick Corporation is recalling specific lots of PureWick external catheter for women Wicks, Item #625. Customers are informed that PureWick is recalling PureWick Wicks because labeling on product shipped prior to February 22, 2017 either did not contain the phrase This product contains dry natural rubber and/or erroneously included the phrase Latex-free. The white gauze component of the PureWick Wick contains dry natural rubber. PureWick Corporation has received zero complaints or reports of adverse events related to the error in labeling. Customers are informed of the risk to health and the actions to be taken. Customers are instructed to complete the enclosed PureWick Field Correction form and fax to PureWick Corporation at (619) 660-5459 or email to response@purewick.com. Customers with questions or would like assistance completing the PureWick Field Correction Form are instructed to call PureWick toll-free at (844) 584-0734 Monday Friday from 8:00 a.m. to 4:30 p.m., Pacific Time.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Lot may contain the wrong instruction (instruction for chinese customer) instead of correct us instructions for use.
Acción
Corentec sent an Medical Device Recall letter dated February 23, 2017. The recalling firm notified the consignee via written notification by email and by phone. The recalled products will be returned to the recalling firm.
For further questions please call (512) 327-9997
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic received a complaint that there was an error code
displayed on the programmer when the physician attempted
to interrogate an implanted synchromed ii pump. the error
code prevented the physician from updating the pump;
however the pump was providing therapy.
Acción
A Medtronic representative visited the clinic on 2/9/2017 and corrected the SynchroMed II pump by resetting the pump memory using a SynchroMed Lab Programmer running on a Medtronic laptop with a validated protocol.
Consignee was given a Medtronic "Urgent Medical Device Correction" letter dated February 8, 2017. The letter described the Issue and Actions to be taken by the consignee. For questions contact your Medtronic Representative Medtronic or Neuromodulation Technical Services at 1-800-707-0933.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Shunt, central nervous system and components - Product Code JXG
Causa
Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the stratamr locator tool: when the stratamr valve is set in the incorrect orientation, higher valve opening pressures result leading to a corresponding underdrainage in csf fluid performance. this condition may result in the following adverse health consequences: ventriculomegaly, headaches, nausea, vomiting and lethargy. if left untreated, underdrainage has the potential to lead to coma and death.
Acción
The firm has initiated a CAPA and issued notification via letter to US Customers on February 22, 2017. As of the date of the report (2/22/17) the firm was still in process of notifying foreign customers. Recipients are instructed to:
1) Cease use of the listed product,
2) Account for number of product units implanted or discarded and return any unused units by completing an attached individualized customer product accountability form provided in the letter,
3) If any of the indicated products have been implanted in patients, to adjust the valves according to instructions listed in an included attachment.
Recipients are asked to fax a customer acknowledgment response form or scan/take a picture of the form and email to rs.mnsfca@medtronic.com with "StrataMR Recall" in the subject line.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Introducer, catheter - Product Code DYB
Causa
Merit medical systems, inc. announces a voluntary field action for sheaths included with the 7f prelude¿ short sheath introducers because the sheath marker tips may detach during use.
Acción
Consignees notified on 2/16/17 to immediately stop using or distributing the affected lots and return them to Merit. For any questions, please contact your Merit Sales Representative or Merit Customer Service at 801.208.4381.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Ventricular (assisst) bypass - Product Code DSQ
Causa
Product recall of all hvad controllers currently on the market and to exchange them for the next generation hvad controller (controller2.0).
Acción
The firm will release a communication to their consignees stating the following:
As a reminder, as with all HVAD Controllers, continue to reinforce the following with your patients and staff at all opportunities:
" Patients should continue to have a backup HVAD Controller ready at all times in the event of a primary HVAD Controller failure.
" Staff only: The driveline extension cable is to be used during the pre-implant test only. It is not intended to be used after the pump is implanted in the patient.
Hospital and Clinician Actions (to be executed in the following order):
1) Review the enclosed notice and forms, and forward the notice to those individuals within your organization who need to be aware of its contents.
2) Complete, sign, and return the Acknowledgement Form to HeartWare within thirty (30) days of receipt of this letter.
4) Quarantine and replace affected HVAD Controllers, DC Adapters, Instructions for Use, Emergency Responder Guides and Patient Manuals in hospital inventory after training is complete.
For every patient, quarantine and replace the following under clinical supervision in an environment where appropriate support equipment is readily available:
- Primary and Backup HVAD Controller;
- Affected DC Adapters; and
- Patient Manual and Emergency Responder Guide.
Clinicians are reminded not to perform an HVAD Controller exchange during an active electrical fault alarm as the HVAD Pump will be running a single stator. If an electrical fault is present, download patient log files and contact your HeartWare representative to resolve the electrical fault before executing the controller exchange.
5) Return all quarantined HVAD Controllers and DC Adapters to HeartWare. Your HeartWare representative will assist you with this process.
6) Completion Form. Once affected product in inventory has been identified and returned, complete and return the attached Completion Form to CON2.0@heartware.com or your HeartWare representative no late
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic is initiating a voluntary urgent medical device recall for a subset of endurant/ endurant ii
bifurcated stent graft systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.
Acción
Medtronic sent an Urgent Medical Device Recall letter dated March 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Our records indicate that your facility has received a potentially affected Endurant /Endurant II 23mm and / or 25mm Bifurcated Stent Graft System from the identified subset. As a result, Medtronic is asking that you take the following actions:
Identify and quarantine unused Endurant /Endurant II 23mm and 25mm Bifurcated Stent Graft System from the identified subset of models and serial numbers that are in your inventory .
Return unused products from the attached model and serial number list that are in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570 (#4) and referencing this communication to initiate a return and credit of unused product.
Your Medtronic sales representative can assist you in the return of this product as necessary.
Complete the attached Customer Confirmation Certificate and email it to RS.CFQFCA@Medtronic.com or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality.
For further questions please call Customer Service at 1 (800) 633-8766.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Instrument, biopsy - Product Code KNW
Causa
The device did not have revolve stereo probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
Acción
Devicor sent an Urgent Medical Device Recall letter dated March 10, 2017 to all affected consignees via first class mail. The recall response rate will be tracked and reconciled by consignee's response form, certifications of product inventory, and/or disposal. Consignees were asked to complete and return the enclosed response form as soon as possible. Consignees with any questions were instructed to call Mammotome Customer Service at 1-877-926-2666. For questions regarding this recall call 513-864-9158.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Product sterility is compromised due to breach of sterile barrier.
Acción
Medtronic/Covidien) initiated recall by letter on March 3, 2017 via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Contact Medtronic representative or Customer Service at (800) 882-5878
For questions regarding this recall call 203-492-5000.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Dressing,wound,occlusive - Product Code NAD
Causa
Product sterility is compromised due to breach of sterile barrier.
Acción
Medtronic/Covidien) initiated recall by letter on March 3, 2017 via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Contact Medtronic representative or Customer Service at (800) 882-5878
For questions regarding this recall call 203-492-5000.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Dressing,wound,occlusive - Product Code NAD
Causa
Product sterility is compromised due to breach of sterile barrier.
Acción
Medtronic/Covidien) initiated recall by letter on March 3, 2017 via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Contact Medtronic representative or Customer Service at (800) 882-5878
For questions regarding this recall call 203-492-5000.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Dressing,wound,occlusive - Product Code NAD
Causa
Product sterility is compromised due to breach of sterile barrier.
Acción
Medtronic/Covidien) initiated recall by letter on March 3, 2017 via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Contact Medtronic representative or Customer Service at (800) 882-5878
For questions regarding this recall call 203-492-5000.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Incorrect priming volume printed on the device package.
Acción
Recall letters were sent to the customer via email and fax on 2/20/2017. They were asked to take the following actions: The recall will be conducted at no cost to you. To effect return of the recalled product and replacement
with new inventory, we request your cooperation in the following steps:
1. Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2. Count and document your affected inventory on the "Recall Acknowledgement and Inventory Return Form; 3. Fax or email the form to Vygon including customer contact information; 4. Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5. Return the product as well as the original signed Recall Acknowledgement and Inventory
Return Form using the instructions from Customer Service involving product pick-up; 6. All inventory will be credited or replaced at no cost to you. If you have questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-4 73-5414, or by e-mail at customerservice@vygonus.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Causa
Zimmer biomet is recalling the altius m-ini oct posterior spinal fixation system because the driver is unable to mate with the screw head tulip.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall letter on March 20, 2017, to all affected consignees. The letter identified the product, the problem and the action to be taken by the consignee. Consignee's Responsibilities
1. Review this notification and ensure affected team members are aware of the contents.
2. Prior to sending Altius Kits to central processing, perform a functional check of the driver withall screws in the kit to ensure they mate. If the drivers do not mate, please return in
accordance with Step 3b.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return
Certification Form Phase I.
b. If the driver is unable to mate with the screws in the set, immediately sterilize and return the
affected nonconforming product from your distributorship and affected hospitals within your
territory along with a completed Attachment 1 Inventory Return Certification Form
Phase I and Attachment 2 Certificate of Sterilization to Zimmer Biomet.
i. For each return, send a copy of Attachment 1 to
jeremy.hansmann@zimmerbiomet.com
ii. Include a hardcopy of Attachment 1 with your shipment for immediate
processing.
iii. Include a copy of Attachment 2 Certificate of Sterilization with returned
instruments.
iv. Mark the outside of the returns box(es) clearly with RECALL.
4. Distributors will notify their accounts to which the product was further distributed and to locate
and return products from these accounts. Using the Additional Accounts Form provided with
the email notice sent to your facility, return contact information for any additional hospitals that
have the affected product. If there are no additional users to notify, please confirm this by
annotating and returning the form provided indicating that no additional users have been
identified.
5. Retain a copy of your field action acknowledgement and product return forms for your records in
the event of a compliance audit of your facility.
6. If
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. such liquids may include disinfectants, cleaning agents and/ or bodily fluids. in rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
Acción
A Customer Safety Advisory Notice (CSAN) was mailed to affected customers on 02/27/2017 to inform them of the issue. The notice provided information on what actions to take should the foot switch fail to function, the risks involved and what corrective actions they are taking to fix the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, angiographic - Product Code IZI
Causa
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. such liquids may include disinfectants, cleaning agents and/ or bodily fluids. in rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
Acción
A Customer Safety Advisory Notice (CSAN) was mailed to affected customers on 02/27/2017 to inform them of the issue. The notice provided information on what actions to take should the foot switch fail to function, the risks involved and what corrective actions they are taking to fix the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. such liquids may include disinfectants, cleaning agents and/ or bodily fluids. in rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
Acción
A Customer Safety Advisory Notice (CSAN) was mailed to affected customers on 02/27/2017 to inform them of the issue. The notice provided information on what actions to take should the foot switch fail to function, the risks involved and what corrective actions they are taking to fix the issue.