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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

GE Healthcare

Class I - Dangerous

Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.

Jan 25, 2018 Diagnostic Equipment Nationwide View Details →

MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

Medline Industries

Class I - Dangerous

The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

Apr 24, 2018 Surgical Instruments Nationwide View Details →

Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

Dynarex

Class I - Dangerous

The device is equipped with a dial that has an inaccurate flow rate indicator.

May 8, 2018 Other Medical Devices View Details →

LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code LX-14; d. Product Code LX-15; e. Product Code LX-16; f. Product Code LX-17; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.

Torax Medical

Class I - Dangerous

Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

Apr 20, 2018 Implants & Prosthetics Nationwide View Details →