Hazard Type

Software Defect Recalls

1,491 product recalls involving software defect. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

1,491Total Recalls
113Critical
36.5MUnits Affected
All Recalls

Every Software Defect Recall

Sorted by most recent. Click any recall for full details and safety information.

1,491 recalls
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that int...
Medical Implants·262 affected·May 26, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·60 affected·May 25, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Medical Devices·424 affected·May 25, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT Upgrade Model 882454
Medical Devices·3 affected·May 25, 2016
High RiskFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for th...
Medical Devices·69,693 affected·May 12, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
Medical Devices·74 affected·May 9, 2016
RecallFDA
Leica Biosystems Richmond Inc.
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the patholog...
Diagnostic Devices·33 affected·May 6, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
Medical Devices·150 affected·Apr 29, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Medical Devices·57 affected·Apr 29, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Medical Devices·276 affected·Apr 29, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
Medical Devices·205 affected·Apr 29, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
Diagnostic Devices·80 affected·Apr 20, 2016
High RiskFDA
Covidien Llc
Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 ...
Diagnostic Devices·12,895 affected·Apr 15, 2016
High RiskFDA
Covidien Llc
Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-031...
Diagnostic Devices·1,305 affected·Apr 15, 2016
RecallFDA
Affymetrix Inc
CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. ...
Diagnostic Devices·507 affected·Apr 14, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, ...
Medical Devices·30 affected·Apr 13, 2016
High RiskFDA
Ion Beam Applications S.a.
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Medical Devices·2 affected·Apr 11, 2016
High RiskFDA
Merge Healthcare, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information man...
Diagnostic Devices·28 affected·Apr 8, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Medical Devices·1,627 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physio...
Cardiac Devices·24 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software.
Medical Devices·217 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Medical Devices·333 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·17 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·29 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare.
Medical Devices·248 affected·Apr 4, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray...
Medical Devices·94 affected·Apr 1, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography...
Medical Devices·19 affected·Apr 1, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray s...
Medical Devices·18 affected·Apr 1, 2016
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure
Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors a...
Medical Implants·5,038 affected·Mar 31, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterizati...
Cardiac Devices·242 affected·Mar 28, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy read...
Medical Devices·534 affected·Mar 28, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical informat...
Medical Devices·198 affected·Mar 28, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X...
Medical Devices·203 affected·Mar 24, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconst...
Medical Devices·8 affected·Mar 24, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction...
Medical Devices·5 affected·Mar 24, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer recons...
Medical Devices·17 affected·Mar 24, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X...
Medical Devices·318 affected·Mar 24, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruc...
Medical Devices·55 affected·Mar 24, 2016
High RiskFDA
Philips And Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating...
Medical Devices·37 affected·Mar 24, 2016
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: T...
Surgical Devices·286 affected·Mar 21, 2016
High RiskFDA
Optovue, Inc.
iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic:...
Medical Devices·40 affected·Mar 16, 2016
High RiskFDA
Merge Healthcare, Inc.
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Medical Devices·555 affected·Mar 10, 2016
High RiskFDA
Philips Visicu
eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use b...
Medical Devices·9 affected·Mar 10, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-q...
Diagnostic Devices·8 affected·Mar 10, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software application...
Medical Devices·33 affected·Mar 4, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Applicat...
Medical Devices·37 affected·Mar 4, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Phi...
Medical Devices·126 affected·Mar 4, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Medical Devices·1,096 affected·Mar 2, 2016