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, communication, powered - Product Code ILQ
Causa
Irregular battery disconnection resulted in issues with mobile health button (mhb) charging.
Acción
Customers were also notified of the recall via an Urgent: Medical Device Recall sent, by US Mail, between 8/19/2015 and 8/20/2015. The letter described the reason for the recall and how to recognize the device failure. The customer is asked to do the following: 1. Review and confirm the attached list of affected units for your program. Contact the affected subscribers listed and notify them that a service visit will be scheduled so that their units can be replaced within the next few weeks. 2. If any subscribers report any issues with their MHB, contact Philips for an expedited unit replacement and instruct them to discontinue use. 3. Philips Customer Care will follow-up with customers via telephone to ensure that they have received and understood the notification. During this follow-up call, we will also confirm arrangements for unit replacements.
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
Prosthesis, rib replacement - Product Code MDI
Causa
The last hole on certain veptr inferior cradles may be partially formed. fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to rib sleeve breakage, and may require surgury to exchange components. effects may also include pain, loss of deformity correction, and/or soft tissue/visceral injury.
Acción
Urgent recall letters, dated July 29, 2015, were sent to end users alerting them to the problem, the associated risk to patients, and provided instruction to return affected devices withthe response form.
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.
Fuses with the improper amperage rating were installed in the symbia s, symbia t series and symbia lntevo systems. these fuses, in conjunction with a specific failure mode of the power controller assembly, could lead to the overheating of the assembly.
Acción
Siemens has sent an undated Customer Advisory Notice letter to all direct accounts (customers). The letters include instructions for customers to: 1) Continue to use the system(s) while waiting for the field correction to be scheduled and performed unless the user observes a burning smell or sees evidenve of smoke. the user should engage the emergency stop, power down and discontinue use of the system, and contact the local service representative. 2) Ensure that this advisory is placed in the system's instructions for use. Siemens reminds the user to observe the patient during studies. 3) If the product was sold to another party, forward the letter to the party. A local service engineer will contact the customer to schedule the servicing of the affected units by September 2015 which will consist of replacing the affected fuse with the correct amperage rating fuse. If you have any questions regarding the important notice, please contact your local service representative by calling 1-800-888-7436. Europe, Middle East and Africa: +49 9131 940 4000. Asia and Australia: +86 (21) 3811 2121.
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
Retractor - Product Code GAD
Causa
Potential for micropores to form, allowing fluid to enter the hollow handle.
Acción
Urgent recall letters, dated July 29,2015, were sent to end users and sales consultants to inform them of the issue, potential risks, and to provide instructions for returning affected devices and the response form.
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
Laparoscope, general & plastic surgery - Product Code GCJ
Causa
There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.
Acción
Lumenis sent an Urgent Medical Device Recall letter on August 7, 2015, to all consignees. Consignees were instructed to destroy the operator manual, and return the affected device to Lumenis along with the completed Recall Verification form. Consignees with questions were instructed to call 801-656-2663.
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
Apparatus, exhaust, surgical - Product Code FYD
Causa
The fluid coupling sleeve, a component within the neptune waste management system docker, may be out of specification. this can cut or dislodge the ptfe seal and cause a leak between the rover and docker couplers during docking or leaking from the rover coupler after docking. the potential hazard is waste fluid and/or fresh water dispensed from the neptune 2 rover at the incorrect time.
Acción
Stryker sent an Urgent Medical Device Notification letter dated August 4, 2015 via FedEx to all domestic customers, and all international cutsomers and sales reperesentatives were notified via e-mail. The letter identified the affected product, problem and actions to be taken. Customers are asked to complete the response form and return it to Stryker whether they have affected devices or not. Fax the completed, signed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to kellyjo.davis@stryker.com. For questions regarding this recall, contact Stryker Instruments at 269-389-2921.
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.
Fuses with the improper amperage rating were installed in the symbia s, symbia t series and symbia lntevo systems. these fuses, in conjunction with a specific failure mode of the power controller assembly, could lead to the overheating of the assembly.
Acción
Siemens has sent an undated Customer Advisory Notice letter to all direct accounts (customers). The letters include instructions for customers to: 1) Continue to use the system(s) while waiting for the field correction to be scheduled and performed unless the user observes a burning smell or sees evidenve of smoke. the user should engage the emergency stop, power down and discontinue use of the system, and contact the local service representative. 2) Ensure that this advisory is placed in the system's instructions for use. Siemens reminds the user to observe the patient during studies. 3) If the product was sold to another party, forward the letter to the party. A local service engineer will contact the customer to schedule the servicing of the affected units by September 2015 which will consist of replacing the affected fuse with the correct amperage rating fuse. If you have any questions regarding the important notice, please contact your local service representative by calling 1-800-888-7436. Europe, Middle East and Africa: +49 9131 940 4000. Asia and Australia: +86 (21) 3811 2121.
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.
Fuses with the improper amperage rating were installed in the symbia s, symbia t series and symbia lntevo systems. these fuses, in conjunction with a specific failure mode of the power controller assembly, could lead to the overheating of the assembly.
Acción
Siemens has sent an undated Customer Advisory Notice letter to all direct accounts (customers). The letters include instructions for customers to: 1) Continue to use the system(s) while waiting for the field correction to be scheduled and performed unless the user observes a burning smell or sees evidenve of smoke. the user should engage the emergency stop, power down and discontinue use of the system, and contact the local service representative. 2) Ensure that this advisory is placed in the system's instructions for use. Siemens reminds the user to observe the patient during studies. 3) If the product was sold to another party, forward the letter to the party. A local service engineer will contact the customer to schedule the servicing of the affected units by September 2015 which will consist of replacing the affected fuse with the correct amperage rating fuse. If you have any questions regarding the important notice, please contact your local service representative by calling 1-800-888-7436. Europe, Middle East and Africa: +49 9131 940 4000. Asia and Australia: +86 (21) 3811 2121.
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.
Biomet has initiated a recall on biomet spine lineum occ starter flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.
Acción
The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated 7/23/2015 to their Consignees/Customers via certified letter. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of device; remove from circulation; carefully follow instructions on enclosed "Response Form" and complete and return via fax to 303.501.8444; if you have further distributed these devices to medical facilities, you MUST notify them of this action; and return device and form to Zimmer Biomet Spine, 310 Interlocken Pkwy, Ste 120, Broomfield, CO 80021.
Questions related to this notice should be directed to the Quality Engineer at 303-501-8457 Monday through Friday, 8 a.m. to 5 p.m. MST.
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.
Labeling changes were made related to mr conditions that align with standard definitions for mr safe, mr conditional, and mr unsafe. this recall identifies additional trauma external fixation system part numbers that should be considered mr conditional. one serious injury reported.
Acción
Urgent recall letters, dated July 31, 2015, were sent to end users and sales consultants to notifiy them about the issue, the associated risks, and to provide instructions for returning the affected devices and response form.
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
Plate, fixation, bone - Product Code HRS
Causa
These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.
Acción
Wright sent an Urgent Medical Device Recall letter dated July 20, 2015, to all affected customers. Customers were asked to complete the attached response form confirming receipt of the notice and the status of any products on hand, and return a copy to Wright by email (complaints@wmt.com or fax (901)867-7401. Also, if customers have any product in their inventory the product should be sent back to Arlington, TN (ALM). For questions regarding this recall call 901-290-5662.
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,test,thyroglobulin - Product Code MSW
Causa
Beckman coulter, inc. is recalling access thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/ml.
Acción
On 07/28/2015 the firm sent out customer notification letters via first class mail and e-mail.
The firm's letter contained the following instructions:
1. Discard all Access Thyroglobulin reagent pack lots listed in the letter.
2. Evaluate Access Thyroglobulin results <10 ng/mL when using the reagent pack lot numbers listed to determine if controls and/or patients were higher than expected or did not match the clinical status of the patient.
3. At the discretion of the Laboratory Director, notify clinicians that it is possible the Access Thyroglobulin sample results reported by the laboratory were affected by this issue.
The firm's notification letter requests that the information be shared with laboratory staff. If any affected products have been forwarded provide a copy of the letter to them.
The firm requests that customers complete and return the Response Form within 10 days.
Any questions contact the Customer Care Center:
1. From website at http://www.beckmancoulter.com
2. By phone: call 1-800-854-3633 in the United States and Canada.
3. Outside the United States and Canada, contact local Beckman Coulter representative
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 for crossing total occlusions - Product Code PDU
Causa
Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the pioneer plus intravascular ultrasound guided re-entry catheters.
Acción
The Volcano Corporation sent an Urgent Medical Device Recall letter dated July 22, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately quarantine and return all affected product in their inventory. Customers were also asked to complete the attached form and fax back to 866-723-2482. Customers with questions were instructed to call 866-861-8923.
For questions regarding this recall call 978-439-3586.
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
Tomographic imager combining emission computed tomography with nuclear magnetic resonance - Product Code OUO
Causa
Philips healthcare has become aware of a problem in which the ingenuity tf pet/mr pet reconstruction server (prs) database may lock up after an mr acquisition is completed and before a pet acquisition is begun, even though no actual database lockup issue has been reported in the field-installed ingenuity tf pet/mr systems.
Acción
On July 23, 2015 the firm sent Field Safety Notices to their customers.
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
Manual antimicrobial susceptibility test systems - Product Code JWY
Causa
The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible enterococcus facaelis atcc 29212 near the end of shelf life.
the in-date product may also exhibit breakthrough growth of vancomycin susceptible enterococcus facaelis atcc 29212 near the end of shelf life.
Acción
Becton Dickinson (BD) sent US customers a Urgent Product Recall letter dated June 2015, via UPS.
Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was at their facility.
The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 10% of non-respondents to verify receipt of the customer letter.
Any product returned to BD will be quarantined and discarded.
If further assistance is needed, please contact BD Technical Services at 1-800-638-8663.
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
Manual antimicrobial susceptibility test systems - Product Code JWY
Causa
The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible enterococcus facaelis atcc 29212 near the end of shelf life.
the in-date product may also exhibit breakthrough growth of vancomycin susceptible enterococcus facaelis atcc 29212 near the end of shelf life.
Acción
Becton Dickinson (BD) sent US customers a Urgent Product Recall letter dated June 2015, via UPS.
Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was at their facility.
The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 10% of non-respondents to verify receipt of the customer letter.
Any product returned to BD will be quarantined and discarded.
If further assistance is needed, please contact BD Technical Services at 1-800-638-8663.
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
Plate, fixation, bone - Product Code HRS
Causa
These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.
Acción
Wright sent an Urgent Medical Device Recall letter dated July 20, 2015, to all affected customers. Customers were asked to complete the attached response form confirming receipt of the notice and the status of any products on hand, and return a copy to Wright by email (complaints@wmt.com or fax (901)867-7401. Also, if customers have any product in their inventory the product should be sent back to Arlington, TN (ALM). For questions regarding this recall call 901-290-5662.
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, insulin - Product Code LZG
Causa
Punctured blister packages were detected during the packaging process at the manufacturing site. potential for device contamination.
Acción
Elcam Medical sent "Urgent: Stopcock Recall" notices and "Recall Return Response Forms" dated 7/19/2015 to their customers. The recall notification informed the customers of the reason for the recall and the actions they must take. Customers were instructed to cease distribution and quarantine any affected products; return to Elcam Medical the enclosed Recall Return Response Form; and notify their customers as per their recall procedures.
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, insulin - Product Code LZG
Causa
Punctured blister packages were detected during the packaging process at the manufacturing site. potential for device contamination.
Acción
Elcam Medical sent "Urgent: Stopcock Recall" notices and "Recall Return Response Forms" dated 7/19/2015 to their customers. The recall notification informed the customers of the reason for the recall and the actions they must take. Customers were instructed to cease distribution and quarantine any affected products; return to Elcam Medical the enclosed Recall Return Response Form; and notify their customers as per their recall procedures.
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.
Eopa arterial cannula devices in this lot were shipped without the guidewire.
Acción
On July 24, 2015 Medtronic sales representatives began verbally notifying the customers of the issue, requesting quarantine and return of un-used, affected product
Consignees were sent a Medtronic "Urgent Medical device Recall" letter dated August 2015. The letter was addressed to Risk Manger and Health Care Professional. The letter described the problem and the product involved in the recall.
Advised consignees to quarantine and remove the product from their inventory and return it to Medtronic. Requested consignees to complete and return the Customer Confirmation Certificate via email to RS.CFQFCA@Medtronic com or fax to Medtronic 651-367-0612 to the attention of Customer Focused Quality. For questions contact your Medtronic Sales Representative or Lifeline Technical Services at 1-877-526-7890.
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
Screw, fixation, bone - Product Code HWC
Causa
Ortho solutions inc is initiating a recall on behalf of ultos 3.5mm locking screw. the locking thread feature of the screw was not manufactured to specification. as a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. in the event of this occurring the non functioning screw would need to be replaced with an alternativ.
Acción
The firm, Ortho Solutions Group, sent an "Urgent Medical Device Recall" notifications and "Effectiveness or Recall Declaration Forms" dated 14 July 2015. The notification informed the consignee of the issue, clinical risks, how to identify the affected product, and the actions the consignees were requested to take. Requested actions included reviewing product on-hand, ceasing distribution of affected product and arrangement for product to be returned to Ortho Solutions, Inc. within 2 working days. Consignees were also requested to fill out the Recall Declaration Form and return it to Ortho Solutions, Inc. via fax to: 201-335-0759 by 16 July 2015.
If you should have any queries relating to this matter or require any additional information, contact General Manager at 201-906-6175.
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
The tip of the stiffened cannula might break during use
and remain in the patient.
Acción
Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand.
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.
Software defect; programming errors in the blood flow probes eprom. transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads used probe or irrelevant use number.
Acción
Transonic sent an Urgent Medical Device Recall letters and Response Forms dated July 27, 2015 to customers via Certified Mail, email and/or fax. The letter identified the affected product, problem and actions to be taken. Customers are instructed to contact Transonic Systems' Customer Service at 1-800-353-3569 or 1-607-257-5300 to arrange for replacement (repair/exchange) immediately.
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.
Software defect; programming errors in the blood flow probes eprom. transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads used probe or irrelevant use number.
Acción
Transonic sent an Urgent Medical Device Recall letters and Response Forms dated July 27, 2015 to customers via Certified Mail, email and/or fax. The letter identified the affected product, problem and actions to be taken. Customers are instructed to contact Transonic Systems' Customer Service at 1-800-353-3569 or 1-607-257-5300 to arrange for replacement (repair/exchange) immediately.
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.
Software defect; programming errors in the blood flow probes eprom. transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads used probe or irrelevant use number.
Acción
Transonic sent an Urgent Medical Device Recall letters and Response Forms dated July 27, 2015 to customers via Certified Mail, email and/or fax. The letter identified the affected product, problem and actions to be taken. Customers are instructed to contact Transonic Systems' Customer Service at 1-800-353-3569 or 1-607-257-5300 to arrange for replacement (repair/exchange) immediately.