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
Wheelchair, mechanical - Product Code IOR
Causa
Gunnell has received complaints that the gas cylinders used in gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the rehab tough and tilt (tnt), bariatric rehab tough and tilt (btnt), rehab recline and mobility (ram), bariatric rehab recline and mobility (bram), and rehab kidster.
Acción
Gunnell, Inc. sent a Medical Device Correction letters dated November 1, 2011 to all consignees. The letter identified the product, problem, and actions to be taken. The letter states that Gunnell Inc will provide free replacement cylinders and reimburse for each correction verified. The notice instructs customers to complete and return the Response Form. Customers were instructed to notify their customers by including a copy of the correction notice. Question and concerns should be addressed to andy.evancho@gunnell-inc.com. or call 1-800-551-0055, attention Andy Evancho.
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
Wheelchair, mechanical - Product Code IOR
Causa
Gunnell has received complaints that the gas cylinders used in gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the rehab tough and tilt (tnt), bariatric rehab tough and tilt (btnt), rehab recline and mobility (ram), bariatric rehab recline and mobility (bram), and rehab kidster.
Acción
Gunnell, Inc. sent a Medical Device Correction letters dated November 1, 2011 to all consignees. The letter identified the product, problem, and actions to be taken. The letter states that Gunnell Inc will provide free replacement cylinders and reimburse for each correction verified. The notice instructs customers to complete and return the Response Form. Customers were instructed to notify their customers by including a copy of the correction notice. Question and concerns should be addressed to andy.evancho@gunnell-inc.com. or call 1-800-551-0055, attention Andy Evancho.
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
Wheelchair, mechanical - Product Code IOR
Causa
Gunnell has received complaints that the gas cylinders used in gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the rehab tough and tilt (tnt), bariatric rehab tough and tilt (btnt), rehab recline and mobility (ram), bariatric rehab recline and mobility (bram), and rehab kidster.
Acción
Gunnell, Inc. sent a Medical Device Correction letters dated November 1, 2011 to all consignees. The letter identified the product, problem, and actions to be taken. The letter states that Gunnell Inc will provide free replacement cylinders and reimburse for each correction verified. The notice instructs customers to complete and return the Response Form. Customers were instructed to notify their customers by including a copy of the correction notice. Question and concerns should be addressed to andy.evancho@gunnell-inc.com. or call 1-800-551-0055, attention Andy Evancho.
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
Wheelchair, mechanical - Product Code IOR
Causa
Gunnell has received complaints that the gas cylinders used in gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the rehab tough and tilt (tnt), bariatric rehab tough and tilt (btnt), rehab recline and mobility (ram), bariatric rehab recline and mobility (bram), and rehab kidster.
Acción
Gunnell, Inc. sent a Medical Device Correction letters dated November 1, 2011 to all consignees. The letter identified the product, problem, and actions to be taken. The letter states that Gunnell Inc will provide free replacement cylinders and reimburse for each correction verified. The notice instructs customers to complete and return the Response Form. Customers were instructed to notify their customers by including a copy of the correction notice. Question and concerns should be addressed to andy.evancho@gunnell-inc.com. or call 1-800-551-0055, attention Andy Evancho.
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
Wheelchair, mechanical - Product Code IOR
Causa
Gunnell has received complaints that the gas cylinders used in gunnell manual wheelchairs with dynamic recline would not hold a firm position, or as described by users, the back support or canes were spongy.
Acción
Gunnell, Inc. sent a Medical Device Correction letters dated November 1, 2011 to all consignees. The letter identified the product, problem, and actions to be taken. The letter states that Gunnell Inc will provide free replacement cylinders and reimburse for each correction verified. The notice instructs customers to complete and return the Response Form. Customers were instructed to notify their customers by including a copy of the correction notice. Question and concerns should be addressed to andy.evancho@gunnell-inc.com. or call 1-800-551-0055, attention Andy Evancho.
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
Bit, drill - Product Code HTW
Causa
Synthes is initiating a recall of the drill bit for 5.0mm recon screws with large quick coupling due to the potential for the drill stop to slip on the drill bit.
Acción
On November 2, 2011 the firm sent "Notice: Medical Device Recall" letters to all consignees, with return receipt request. The letter requested consignees cease use of the device and remove the product from inventory. For questions, call 610-719-5450 or contact your sales consultant.
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
Cement, dental - Product Code EMA
Causa
The specific lots of maxcem elite refill kit appear not to be authentic.
Acción
The firm, Henry Schein, Inc., sent an "URGENT: Product Recall (Dental Practitioners/User Level) letter and response form dated November 10, 2011, via first class mail to its customers. The letter instructed the customers to examine their inventory to verify if they have any of the specified lots on hand. If so, remove it from their shelves. The product may be returned for credit within 30 days, to the following address: Henry Schein, Inc., 41 Weaver Road, Denver, PA 17517. Additionally, the letter instructed the customers to complete, sign, date, and return the enclosed Henry Schein Response Form via fax to: (631) 843-5557 or mail to: Regulatory Affairs Department (E-355) 135 Duryea Road, Melville, NY 11747, Attn: Regulatory-RR.
The letter stated "Only returns of the above noted recalled item/lot numbers purchased from Henry Schein, Inc. will be credited to your account. In order to expedite your credit, please include a copy of your response form and invoice, if available, with your return".
If you have any questions regarding this matter, please contact Recall Coordinator at 631-390-8000 ext. 8476.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
The float valve in the burette sticks to the burette wall and does not open or close properly.
Acción
The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated November 10, 2011 to the customers of record via UPS on the same date. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return Reply Form via fax to 1-866-913-0667 or email to: hospira2530@stericycle.com; return affected product to Stericycle using the label provided with this letter; and if they have distributed the product further, notify their accounts that received the product .
Please contact Hospira Customer Care at 1-877-946-7747 or your Hospira representative for information regarding product availability.
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.
Vital images has found two issues that may display incorrect standard update values (suv) when viewing certain pet/ct images. this issue affects the vitreacore pet/ct feature for vitrea enterprise suite 1.2, 1.3, 6.0, 6.1, including all updates to those versions.
Acción
Vital Images, Inc. sent an URGENT DEVICE RECALL letter dated November 11, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to inform all potential users of the issues. Customers were to be contacted by their Service Account Manager to discuss and schedule resolutions.
For questions customers were to contact Vital Images Customer Support with any questions toll free at 1-800-208-3005, in Europe +31 (0) 70 4135801, in Asia t +86 10 8588 1800, or online at support@vitalimages.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
Hip Prosthesis - Product Code LPH
Causa
Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. in 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production and had not been included in the 2006 recall.
Acción
On 11/16/11, Zimmer sent letters titled "URGENT MEDICAL DEVICE RECALL" to distributors via electronic mail and to risk managers and surgeons via FedEx indicating that the product must be immediately removed from use and quarantined.
" Stop using the affected lots and place affected product in quarantine.
" Review available product on the shelf
" Identify those part/lot combinations listed in the recall communication
" Immediately remove any implants found that match part/lot combinations listed in the recall communication and quarantine
" Return affected lots and signature of acknowledgement to Zimmer
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
Calculator/data processing module, for clinical use - Product Code JQP
Causa
Soft computer, clearwater, fl, initiated a correction on the following softpath gui versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. softpath architecture does not correctly handle ap macros and data fields inside report sections that are stored in the database. improper information can be displayed in all places where the diagnosis from the database is read and displayed.
Acción
The firm, SCC Soft Computer, sent a "CORRECTION COMMUNICATION" notice on July 13, 2011 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to restrict security access to the template set-up files and to acknowledge receipt of the notice; grant SCC personnel permission to check their report templates and correct any that are affected; indicate if they wish to schedule the utility to be run and if they would like to have the SoftWeb parameter PathPDFLinkOnly set to "Y". SCC will review the templates on the customers systems; discuss any irregularities requiring change and move or remove AP macros and data elements as needed.
If you have any questions, contact the Director of Quality Management at (727)789-0100.
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 microfixation, inc., jacksonville, fl, recalled their iq intelligent device, 72-1000 due to failure of the front bit sensor to detect the correct bit that is installed. when a screw is inserted with the device in drill mode, it is possible for the screw or bone to strip.
Acción
Biomet Microfixation called, emailed, or sent an Urgent Medical Device Recall letter dated July 8, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the remaining device(s) at their facility and return immediately to PIVOT for the required software upgrade. Customers were also instructed to return the attached reconciliation form to:
PIVOT International
10916 Strang Line Road
Lenexa, KS 66215
Attn: Julie Lawrence
For any questions regarding this recall call 1-800-874-7711 or 904-741-4400, ext 9468.
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
Hip Prosthesis - Product Code LPH
Causa
Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. in 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production and had not been included in the 2006 recall.
Acción
On 11/16/11, Zimmer sent letters titled "URGENT MEDICAL DEVICE RECALL" to distributors via electronic mail and to risk managers and surgeons via FedEx indicating that the product must be immediately removed from use and quarantined.
" Stop using the affected lots and place affected product in quarantine.
" Review available product on the shelf
" Identify those part/lot combinations listed in the recall communication
" Immediately remove any implants found that match part/lot combinations listed in the recall communication and quarantine
" Return affected lots and signature of acknowledgement to Zimmer
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
Laboratory information System - Product Code LNX
Causa
Potential for patient data to be sent to the wrong patient record. a software change affected how the softlab handles recovery from certain types of table access conflicts. when such conflicts occur, this function has the potential to cause faulty writing to the database.
Acción
Clients were notified through SCC Soft Computer's proprietary Task Management System On 03/22/201. All clients have received a hot fix that corrected the issue or made the hosparam change that prevents 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
Hip Prosthesis - Product Code LPH
Causa
Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. in 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production and had not been included in the 2006 recall.
Acción
On 11/16/11, Zimmer sent letters titled "URGENT MEDICAL DEVICE RECALL" to distributors via electronic mail and to risk managers and surgeons via FedEx indicating that the product must be immediately removed from use and quarantined.
" Stop using the affected lots and place affected product in quarantine.
" Review available product on the shelf
" Identify those part/lot combinations listed in the recall communication
" Immediately remove any implants found that match part/lot combinations listed in the recall communication and quarantine
" Return affected lots and signature of acknowledgement to Zimmer
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.
Presence of silicone oil residue on avaira sphere soft contact lenses.
Acción
CooperVision Inc. issued a press release on November 15, 2011. An "URGENT: MEDICAL DEVICE RECALL- AVAIRA SPHERE CONTACT LENSES" letter dated November 16, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their inventory, stop further distribution of the affected product, contact their patients and to advise their patients to check the firm's website to confirm they have the affected product. Additionally, a response form was included with the letter for customers to complete and return via fax at 866-484-1048. Contact Coopervision at 800-341-2020 for questions regarding this recall
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
Medical computers and software - Product Code LNX
Causa
On 05/03/2011 scc soft computer, clearwater, fl initiated a correction on the following softlab gui versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. a client reported the pt and inr results did not get flagged. the prot should have been flagged as high and the inr should have been flagged as panic. neither test was flagged. all affected clients were notified of the issue on 05/03.
Acción
SCC Soft Computer initiated a Field correction on May 3, 2011. All customers with affected software have been notified of this issue. Clients were instructed to have a "valcheck" utility run to determine if there are any tests in their system affected by the issue. They were supposed to indicate whether they wanted to schedule to receive the patch or hot fix.
If you have any further questions please call ( 727 ) 789-0100.
Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
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
Accelerator, linear, medical - Product Code IYE
Causa
User facility reported an anomaly where inhale and exhale ct pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery.
Acción
Accuray sent a Urgent Medical Device Correction letter dated November 7, 2011, via Federal Express to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The information provided in this letter will be incorporated in user manuals shipped with the CyberKnife system.
If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at 1. (877) 668-8667 ( USA)
1. (408) 716-4700 ( non USA )
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 is being recalled due to unintended movement on the titan tables.
Acción
Trumpf Medical Systems sent an initial notification to customers dated January 24, 2011. A subsequent "URGENT SAFETY NOTICE-UPDATE" letter dated May 26, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. A Corrective Action Plan includes a software update to be installed by a Trumpf Technical Service Representative. Contact Technical Service at 888-474-9359 for questions regarding this notice.
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 is being recalled due to unintended movement on the titan tables.
Acción
Trumpf Medical Systems sent an initial notification to customers dated January 24, 2011. A subsequent "URGENT SAFETY NOTICE-UPDATE" letter dated May 26, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. A Corrective Action Plan includes a software update to be installed by a Trumpf Technical Service Representative. Contact Technical Service at 888-474-9359 for questions regarding this notice.
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 is being recalled due to unintended movement on the titan tables.
Acción
Trumpf Medical Systems sent an initial notification to customers dated January 24, 2011. A subsequent "URGENT SAFETY NOTICE-UPDATE" letter dated May 26, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. A Corrective Action Plan includes a software update to be installed by a Trumpf Technical Service Representative. Contact Technical Service at 888-474-9359 for questions regarding this notice.
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
Support, patient position - Product Code CCX
Causa
C-flex polar head positioner may have an adjustment screw loosen and affect load capacity.
Acción
Allen Medical Systems sent a Urgent Medical Device Recall Notification dated November 18, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Allen Medical will provide packaging materials and instructions for returning your device for repair at not cost to you. Each unit will be repaired and tested. Devices which pass all testing will be returned to the field.
For further questions please call 888-521-4277 ext. 4280
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 this action following an investigation which identified that part 150367, (oss
cemented 1m stem 13x150) was incorrectly labeled as part 150368 (oss cemented 1m stem
14x150).
Acción
Biomet, Inc. sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 1, 2011 to the one distributor with the affected product. The letter described the product, problem, and actions to be taken by the customer. The letter instructs the customer to immediately locate and remove the affected product from inventory. Additionally, the customer was asked to complete and return a Response Form via fax to 574-372-1683. Call 574-372-3983 for questions related to this notice.
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
Medical computers and software - Product Code LNX
Causa
On 06/13/2011, scc soft computer initiated a correction on the following softpath gui versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. a client reported when they verified the contents of the fax reports, they found one of the specimen diagnoses to be missing. parts a through d were present as well as part f, however, part e diagnosis was missing for one of the patient reports. all affected clients wer.
Acción
SCC Soft Computer initiated a Field Correction on June 13, 2011. All customers with affected software have been notified of this issue.
SCC recommends until the corrected patch is loaded to temporarily use one of the following alternative working solutions:
1. Use MS Word Editor functionality within SoftPath application for creating patient reports. In order to ensure Text Control editor is not inadvertently activated, the templates for Text Control editor will be deleted and reinstalled at the clients request by their SCC representative after receipt of the correction.
2. In Report Template set-up, the bottom margin should be made slightly larger than the size of the footer plus its distance from the bottom page border.
For further explanation, please consult your SCC representative for further details, or call (727) 789-0100.