All Recalls

95,089 total recalls in our database

A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.

Dec 6, 2016 Surgical Instruments Nationwide View Details β†’

Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Siemens Medical Solutions USA

πŸ₯ Medical Devices Class I - Dangerous

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Dec 13, 2016 Diagnostic Equipment Nationwide View Details β†’

iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).

Oct 31, 2016 Implants & Prosthetics View Details β†’

Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.

Dec 8, 2016 Diagnostic Equipment Nationwide View Details β†’

Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.

Nov 3, 2016 Infusion Pumps Nationwide View Details β†’

GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

Dec 19, 2016 Diagnostic Equipment Nationwide View Details β†’

Reunion TSA Peg Alignment Sound broke during surgery.

Dec 2, 2016 Implants & Prosthetics Nationwide View Details β†’

Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Siemens Medical Solutions USA

πŸ₯ Medical Devices Class I - Dangerous

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Dec 13, 2016 Diagnostic Equipment Nationwide View Details β†’

Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.

Sep 27, 2016 Infusion Pumps Nationwide View Details β†’

Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.

Nov 29, 2016 Surgical Instruments View Details β†’

There's a potential for liquid penetration into the back side of the front control panel of the X-ray diagnostic table, which can cause a short circuit of the terminals of the tilt operation and cause an unintentional tilt of the table.

Nov 18, 2016 Other Medical Devices Nationwide View Details β†’

Mobiles

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The wheels on the mobile's hanging cars can detach and fall, posing a choking hazard to young children.

Jan 17, 2017 Children's Products Nationwide View Details β†’
🏠 Consumer Products Class II - Moderate

The vehicles can unexpectedly roll away when in the "park" or "P" position, posing an injury hazard to users.

Jan 12, 2017 Other Consumer Products Nationwide View Details β†’

Pre-Lit Globe Light Christmas trees

Baozhaolai Metal Manufactory (Huizhou Co. Ltd.), of Guangdong, China.

🏠 Consumer Products Class I - Dangerous

The fuse on the product can overheat and blow, posing a fire hazard.

Jan 12, 2017 Other Consumer Products Nationwide View Details β†’
🍎 Food Class I - Dangerous

The item is subject to Import Alert 21-04 in that it appears to bear or contain cyclamate and dulcin which are unsafe food additives, the item does not declare saccharin on it's labeling and the the product appears to contain or bear the following unsafe color additive such as FD&C Yellow #5 (C.I. No. 19140 - tartrazine) FD&C Red #3 (C.I. No. 45430 - Erythrosine), and Carmoisine (C.I. No. 14720 - former ext. D&C Red #10).

Nov 23, 2016 Other Foods View Details β†’