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
Xvi can incorrectly calculate the target position of the treatment table.
Acción
Elekta is responsible for the correction of all products with this defect.
1. Notifications regarding the possibility of this software error and subsequent table location error and potential hazards have been sent out. The notifications include steps to take to reduce the possibility of the occurrence of an injury.
2. A software correction has been released for some versions of the XVI software. All versions of software with this error will be corrected by the end of July 2014.
3. The software correction will enable verification that values have been assigned to table position parameters; failure to pass verification will inhibit the system. The software correction will also detect internal communication errors (incomplete registrations) and inhibit the system when those errors are detected.
4. The update will be mandatory and will be made at no cost to the users.
CDRH approves this CAP. You may proceed with implementation of the CAP.
For further questions please call (770) 670-2422.
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
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
Software anomaly: potential buffer timeout issues when using engen (tm) laboratory automation systems configured with tcautomation (tm) software v3.5.
Acción
Ortho Clinical Diagnostics sent an Important Product Correction Notification dated April 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
On April 17, 2014, foreign affiliates were informed by e-mail of the issue and instructed to notify their customers of the issue and actions.
The letters instruct customers: to ensure that samples prematurely routed to Check are detected and processed appropriately, please monitor completion of all pending tests following standard laboratory practice. Customers were informed of the issue and advised to: -- Routinely monitor pending result reports from your Laboratory Information System (LIS) to determine if results are pending for samples. -- Investigate to determine the next action identified for a sample if the sample is routed to the Check location prematurely.
If you have any additional questions, please call Customer Technical Services at 1-800-421-3311.
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
Analyzer, Chemistry (photomertic, discrete), for clinical use - Product Code JJE
Causa
Software anomaly: potential for delay in the reporting of patient sample test results when using engen with tcautomation software v2.6 , v3.2 and v3.5 configured with bypass modules for advia centaur, abbott architect, vitros and/or tosoh aia systems.
Acción
Urgent Product Correction Letters (CL2014-114, dated 4/10/2014) were sent to all US customers and Foreign affiliates starting on 4/10/2014. The letter informed customers of the issue and provided required actions to be taken: Routinely monitor your Bypass module(s) -- If you detect a stoppage due to the software timing issue, follow the steps in the How to Detect the Bypass Module Time Issue and Release the Samples section on Page 2 of this notification. -- Complete the Confirmation of Receipt Form and return by 4/23/2014. -- Place this notification near each system or with your enGen (TM) Laboratory Automation System user documentation.
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
clinical chemistry analyzer - Product Code JJE
Causa
Potential for biased results when a multiple window (mw) code is associated with results generated by the vitros 4600 chemistry system, the vitros 5600 integrated system and the vitros 5,1 chemistry system. mw codes may be associated with results from any of the following vitros chemistry products using multiple point (multipoint) rate measurements. the microslide assays that could be affected.
Acción
Important Product Correction Letters (CL2014-116, dated 4/10/2014) were sent on 4/10/2014 via FedEx overnight courier or ORTHO PLUS e-Communications to all customers with VITROS 5,1 FS, 5,1 FS Refurbished, 4600,and/or 5600 Systems. They were informed of the issue and advised to: -- Review VITROS ALT, ALTJ, ALKP, ALKPJ, AST, ASTJ, CHE, CHEJ, CK, CKJ, GGT, GGTJ, LDH and LDHJ results generated on VITROS 4600/5600 and 5,1 FS Systems. Do not report any results associated with an MW code. -- Perform repeat testing in singlicate on all samples with results having an MW code. Only results without an MW code are acceptable. -- Review their current Laboratory Information System (LIS) configuration to determine if changes are required in order to restrict reporting of results with an MW code. Customers with questions should contact Customer Technical Services at 1-800-421-3311. --- Foreign affiliates were informed of the issue by e-mail on 4/10/2014 and instructed to notify their consignees of the issue and actions.
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
clinical chemistry analyzer - Product Code JJE
Causa
Potential for biased results when a multiple window (mw) code is associated with results generated by the vitros 4600 chemistry system, the vitros 5600 integrated system and the vitros 5,1 chemistry system. mw codes may be associated with results from any of the following vitros chemistry products using multiple point (multipoint) rate measurements. the microslide assays that could be affected.
Acción
Important Product Correction Letters (CL2014-116, dated 4/10/2014) were sent on 4/10/2014 via FedEx overnight courier or ORTHO PLUS e-Communications to all customers with VITROS 5,1 FS, 5,1 FS Refurbished, 4600,and/or 5600 Systems. They were informed of the issue and advised to: -- Review VITROS ALT, ALTJ, ALKP, ALKPJ, AST, ASTJ, CHE, CHEJ, CK, CKJ, GGT, GGTJ, LDH and LDHJ results generated on VITROS 4600/5600 and 5,1 FS Systems. Do not report any results associated with an MW code. -- Perform repeat testing in singlicate on all samples with results having an MW code. Only results without an MW code are acceptable. -- Review their current Laboratory Information System (LIS) configuration to determine if changes are required in order to restrict reporting of results with an MW code. Customers with questions should contact Customer Technical Services at 1-800-421-3311. --- Foreign affiliates were informed of the issue by e-mail on 4/10/2014 and instructed to notify their consignees of the issue and actions.
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.
Convatec inc. is recalling flexi-seal fms control kit since it does not have a 510k. in addition, an internal assessment of product performance, including a review of customer
feedback, has confirmed that flexi-seal control is not meeting expectations or those of customers. specifically, the auto-valve feature that is unique to the flexi-seal control
has not been consistently performing relative.
Acción
Convatec Inc. sent an Urgent Voluntary Medical Device Recall letter dated April 29, 2014 via UPS. The letter identified the affected product, problem and actions to be taken. Customers are asked to immediately stop distributing and quarantine all recalled lots. Affected products must be returned to Distributor. Contact your Distributor for shipping instruction. Customers should completed the attached return response form and return it to the address on the response form. Questions can be directed to Gregory Kowzun at (336) 547-3710. Convatec issued a press release on 7/3/2014.
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
There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of continuum systems shipped prior to march 2008.
Acción
Bayer sent an Urgent Medical Device Recall and Removal Letters dated April 3, 2014, and April 30, 2014, were sent to direct accounts to notify them of the bracket issue and to provide additional instructions for testing and/or returning the brackets.
As a critical medical needs site currently using Continuum with a recalled bracket you have two options:
1. Immediately return your Continuum(s) for refund.
2. Take actions to ensure continued safe use of your system associated with the bracket recall. You will still be eligible for a refund when you return the system no later than June 30, 2015.
When you are ready to return your Continuum(s), please refer to:
¿ Enclosure 2: Disassembly Instructions.
¿ Enclosure 3: Continuum Return Form.
We sincerely regret the inconvenience and impact of the recalls and subsequent removal of Continuum from the market. Should you have questions regarding the pro-rated refund program, please call 877-229-3767.
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
Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
Causa
The keyboard and monitor may not be properly secured to the monitor arm.
Acción
Siemen's Healthcare Diagnostics sent an Urgent Medical Device Correction letter dated April 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return teh Field Correction Effectiveness Check form attached to the letter within 30 days by fax to 302-631-7597.
Inspect the monitor, keyboard and bracket assembly. If the screw and washer assembly is secure as shown in Figure 1, the monitor and keyboard assembly is safe to use.
After making adjustments or repositioning the monitor, keyboard and bracket assembly, inspect the screw adn washer to ensure it is ssecure as shown in Figure 1.
If there is a gap between the underside of the monitor support bracket and cylindrical
mounting feature as shown in Figure 2, contact your Siemens technical support
representative to schedule a service visit as soon as possible. Front load and manage samples directly on the connected instruments until your Siemens technical support representative addresses the issue.
Customers were instructed to retain the letter with their laboratory records, and forward the letter to those who may have received the affected product.
Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative.
For questions regarding this recall call 877-229-3711.
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.
Difficulty removing the cup adaptor from the impaction handle during surgery.
Acción
Firm has initiated the recall by email on 04/28/2014 to all distributor's offices, including international, then followed with written communication on 05/02/2014 via Fed Ex P1 delivery to all United States consignees. Follow-up to non-responding consignees will commence 30 days after initiation.
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
Glucose oxidase, glucose - Product Code CGA
Causa
Jas diagnostics, inc. of miami lakes, fl is recalling their glucose hexokinase reagent due to certain lots not performing according to their specifications.
Acción
JAS Diagnostics, Inc. sent an Important Product Recall Information letter dated April 7, 2014 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The customers were instructed to: 1) Screen their inventory for any of the lots listed in the letter and discontinue use immediately. 2) Contact the Customer Service Department at 305-748-2762 or 305-748-2763 to obtain replacement product.
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
C. Difficile nucleic acid amplification test assay - Product Code OMN
Causa
Illumipro-10 instruments may have block b chambers operating at an incorrect temperature as a result of incorrect temperature calibration.
Acción
Meridian sent an Urgent Medical Device Recall letter dated April 25, 2014, 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 return their unit to Meridian Bioscience. Meridian's Technical Support Staff will call them directly to provide them with a return authorization number and instructions for decontaminating, packaging and shipping the unit. For additional information customers were instructed to call 800-343-3858 (North America or 513-271-3700 (Worldwide).
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, autotransfusion - Product Code CAC
Causa
Product that was previously recalled because the chest drain tubing of the ats blood recovery may leak or disconnect, was released for distribution in error.
Acción
Smith & Nephew notified Distributors on April 28, 2014 by telephone. A follow up e-mail and a recall notification letter were issued by UPS on 6/27/14. Distributors were requested to notify customers who received the lot. A reply acknowledgement form was to be completed and returned. Return Goods Authorizations for the return of the goods were issued to 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
Regulator, pressure, gas cylinder - Product Code CAN
Causa
Separation events have occurred, including the vipr separating from the aluminum cylinder.
Acción
All initial consignees of subject product were notified by letter dated June 5, 2014 via U.S. mail. Initial consignees were directed to forward copies of the recall notification letters to their contacts in the event the subject product has been further distributed.
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.
Codan us corporation is recalling the colorsafe iv (intravenous) product lines because they were manufactured and marketed prior to fda approval.
Acción
CODAN sent a recall letter dated August 17, 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 return any of the affected product. If they sold the product they should provide Codan the name and address of the customer. so that they may be contacted to retrieve the shipped products. Customers were instructed to contact CODAN Customers Service for a Returned Goods Authorization. Customers with questions were instructed to call 714-430-1303. Customers were instructed to not send used devices.For questions regarding this recall call 714-545-2111.
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.
Notas adicionales en la data
Implant, dermal, for aesthetic use - Product Code LMH
Causa
Manufacturer made a change in the production process that resulted in a change in final gel weight. recall expanded 7/8/2014 firm expanded their recall to include all lots of product.
Acción
Enhancement Medical, LLC called all Independent Sales Representatives and then provided each representative a list of consignees with impacted product and instructed the Representatives to disclose low gel weight issue and potential for common treatment responses. Representatives were instructed to exchange the affected product.
EXPANDED Enhancement Medical sent an Urgent Medical Device Recall letter beginning July 8, 2014 to all consignees whom received product. The letter identified all lots as being recalled, the reason for the recall, recommended that Expression not be injected subcutaneously, and asked for product to no longer be used and be returned to the recalling firm. An acknowledgement Form was asked to be mailed, e-mailed or faxed back to the firm.
Customers with questions were instructed to call 414-918-4280.
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.
Siemens medical solutions usa, inc. has received reports indicating the collimator cart rear casters may become loose.
Acción
A Customer Safety Advisory Notice dated April 23, 2014 was sent to every direct account. The letter included instructions for direct accounts to discontinue use of the collimator cart and notify the local service representative if they notice or suspect tha one or more casters are loose (which would be indicated by shaking while the cart is in motion). Otherwise, a service representative will be contacting the direct account within the following 3 months to schedule a retention bracket installation. Direct accounts with questions can contact Siemens Medical Solutions USA, Inc. at 800-888-7436.
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.
Siemens medical solutions usa, inc. has received reports indicating the collimator cart rear casters may become loose.
Acción
A Customer Safety Advisory Notice dated April 23, 2014 was sent to every direct account. The letter included instructions for direct accounts to discontinue use of the collimator cart and notify the local service representative if they notice or suspect tha one or more casters are loose (which would be indicated by shaking while the cart is in motion). Otherwise, a service representative will be contacting the direct account within the following 3 months to schedule a retention bracket installation. Direct accounts with questions can contact Siemens Medical Solutions USA, Inc. at 800-888-7436.
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
Fibrinogen and fibrin split products, antigen, antiserum, control - Product Code DAP
Causa
Customer complaints about not repeatable results below the detection limit (<45 ng/ml). therefore false negatives are being reported for results around the medical decision point of 500 ng/ml that initially tested at <45 ng/ml.
Acción
A recall letter was issued on 4/17/2013 to US customers via FED Ex mailing. The letter included a fax back acknowledgment form. A recall notice was also sent via email to bioMerieux Subsidiaries and international distributors on 4/11/2013.
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, nuclear magnetic resonance imaging - Product Code LNH
Causa
The gradient coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
Acción
Letters will be sent to customers. Hatachi Serivce will be sent to each site to exchange the Gradient Coil Assembly.
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.
The firm found that the top cover of the mattresses were delaminating.
Acción
The firm sent out Urgent: Voluntary Field Correction/Removal letters, dated August 11, 2014, to all consignees with instructions for correcting the issue. Customers were to immediately examine their inventory and quarantine any affected product. Customers are to complete and return the response form provided. Questions can be directed to 1-877-638-2776.
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.
The advia chemistry systems a1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (hb)a1c samples when using a1c_3 calibrator lots 3hd044 and 3ld068. depending on quality control limits, this issue may not have been detected. note: the percent bias range is a percentage of the hba1c result. it is not absolute hba1c units.
Acción
Siemens sent an Urgent Field Safety Notice dated August 2014 to all affected consignees on August 6, 2014 via Federal Express. The letter instructed consignees to discontinue use and discard calibrator lots 3HD044 and 3LD068. Customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Distribution of the Urgent Field Safety Notices to foreign consignees was determined at the country level.
For questions regarding this recall call 914-524-2955.
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.
Ge healthcare has recently become aware of a potential safety issue due to a failure of an o2 sensor component associated with the carescape respiratory modules, the airway gas option and their respective service exchange units.
Acción
Consignees were sent on 8/8/2014 a GE Healthcare "Urgent Medical Device Correction" letter Ref# 36106 dated August 8, 2014. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions you can contact Technical Support at 1-800-558-7044 or your local Service 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.
Reports of breakage of the persona knee trial articular surface provisionals (tasps). the persona primary knee surgical technique has been updated. this field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.
Acción
On 8/7/2014, Zimmer notified all distributors via electronic mail. Distributors that have received affected inventory are also notified via courier. Hospital risk managers and surgeons are also notified via courier.
Hospital risk managers and surgeons were provided with a notification identifying the issue and their responsibilities. These responsibilities include ensuring the affected personnel are aware of the contents of the notification.
Distributors were sent a notification identifying the issue and to provide a copy of the notification sent to surgeons and risk managers. The distributors will also be instructed as needed to assist with identifying a comprehensive list of surgeons.
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
Evacuator, gastro-urology - Product Code KQT
Causa
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Acción
Civco Medical Instrucments contacted customers by phone and sent an Urgent Medical Device Recall letter dated August 1, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return all the affected product. Customers were instructed to contact Customer Service at 319-248-6520 with any concerns or questions.