Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 116 of 120
Roche Molecular Systems, Inc.
Class II Terminated
DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Z-0493-2013 December 19, 2012 Branchburg, NJ
Roche Molecular Systems, Inc.
Class II Terminated
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA...
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Z-0488-2013 December 19, 2012 Branchburg, NJ
Siemens Medical Solutions USA, Inc
Class II Terminated
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Reason: Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses...
Z-0465-2013 December 12, 2012 Malvern, PA
Philips Healthcare Inc.
Class II Terminated
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Reason: With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside th...
Z-0475-2013 December 12, 2012 Andover, MA
Natus Medical Incorporated
Class I Terminated
The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap i...
Reason: The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer provid...
Z-0447-2013 December 12, 2012 Seattle, WA
GE Healthcare, LLC
Class II Terminated
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or ...
Reason: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
Z-0450-2013 December 5, 2012 Waukesha, WI
GE Healthcare, LLC
Class II Terminated
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film o...
Reason: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
Z-0449-2013 December 5, 2012 Waukesha, WI
GE Healthcare, LLC
Class II Terminated
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film o...
Reason: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
Z-0448-2013 December 5, 2012 Waukesha, WI
Biomerieux Inc
Class II Terminated
bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most comm...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0311-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients tha...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0319-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are ac...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0301-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Software update for the clinical instrument which is m...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0305-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625 Software update for the clinical instrument which i...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0307-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients tha...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0320-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazilian, Portuguese, catalog number 412950 Software u...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0323-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925 Software update for the clinical instrument which is most common...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0310-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients tha...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0299-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 Software update for an instrument which is most commonly...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0321-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the clinical instrument which is most comm...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0302-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0300-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559 Software update for the clinical instrument which i...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0314-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 Software update for an instrument which is most commo...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0328-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients t...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0318-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for the clinical instrument which is most commonly used to iso...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0304-2013 November 28, 2012 Hazelwood, MO
Biomerieux Inc
Class II Terminated
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626 Software update for the clin...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0308-2013 November 28, 2012 Hazelwood, MO