Category

Diagnostic Devices Recalls

1,863 diagnostic devices recalls on record from CPSC, FDA, and USDA.

1,863 recalls
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·9 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging...
Diagnostic Devices·25 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·23 affected·Mar 6, 2015
High RiskFDA
Bd Biosciences, Systems & Reagents
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
Diagnostic Devices·72 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·215 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·350 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging syst...
Diagnostic Devices·15 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·10 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic...
Diagnostic Devices·31 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·277 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·156 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·36 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic I...
Diagnostic Devices·1 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging ...
Diagnostic Devices·7 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging ...
Diagnostic Devices·376 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·1 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic ...
Diagnostic Devices·126 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·337 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·3 affected·Mar 6, 2015
High RiskFDA
Siemens Medical Solutions Diagnostics
Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform ...
Diagnostic Devices·962 affected·Mar 5, 2015
High RiskFDA
Siemens Medical Solutions Diagnostics
Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemilumin...
Diagnostic Devices·8 affected·Mar 5, 2015
High RiskFDA
Siemens Medical Solutions Diagnostics
Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perfo...
Diagnostic Devices·186 affected·Mar 5, 2015
High RiskFDA
Siemens Medical Solutions Diagnostics
Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perfor...
Diagnostic Devices·15 affected·Mar 5, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use o...
Diagnostic Devices·472 affected·Mar 5, 2015
High RiskFDA
Hardy Diagnostics
Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate...
Diagnostic Devices·840 affected·Mar 4, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare DigitalDiagnost System X-Ray
Diagnostic Devices·54 affected·Feb 9, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended U...
Diagnostic Devices·16 affected·Feb 4, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy i...
Diagnostic Devices·192 affected·Jan 30, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
Diagnostic Devices·9,778 affected·Jan 27, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
Diagnostic Devices·1,719 affected·Jan 27, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
Diagnostic Devices·11,980 affected·Jan 27, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
Diagnostic Devices·71 affected·Jan 23, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_...
Diagnostic Devices·657 affected·Jan 19, 2015
High RiskFDA
Abbott Laboratories, Inc
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette s...
Diagnostic Devices·1,385 affected·Jan 15, 2015
RecallFDA
Siemens Healthcare Diagnostics, Inc.
N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/s...
Diagnostic Devices·26 affected·Jan 15, 2015
CriticalFDA
Ge Healthcare
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa...
Diagnostic Devices·12,968 affected·Jan 7, 2015
High RiskFDA
Sysmex Corporation
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use...
Diagnostic Devices·1,137 affected·Dec 18, 2014
High RiskFDA
Leica Microsystems, Inc.
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is...
Diagnostic Devices·309 affected·Dec 16, 2014
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
Diagnostic Devices·59,965 affected·Dec 15, 2014
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
Diagnostic Devices·32,159 affected·Dec 15, 2014
High RiskFDA
Nordicneurolab As
nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limite...
Diagnostic Devices·16 affected·Dec 15, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic syst...
Diagnostic Devices·11 affected·Dec 15, 2014
High RiskFDA
Genetic Testing Institute,inc
PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13...
Diagnostic Devices·6,206 affected·Dec 15, 2014
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
Diagnostic Devices·31,799 affected·Dec 15, 2014
RecallFDA
Pointe Scientific, Inc.
Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R...
Diagnostic Devices·93 affected·Dec 12, 2014
High RiskFDA
Biocare Medical Llc
MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used...
Diagnostic Devices·59 affected·Dec 12, 2014
High RiskFDA
Ge Healthcare
GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in gene...
Diagnostic Devices·24 affected·Dec 10, 2014
CriticalFDA
Alere San Diego, Inc.
Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 010...
Diagnostic Devices·77,342 affected·Dec 5, 2014