medical Class II Updated 2024-02-07

Philips North America recalls Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.

Recalled Product

Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.


Hazard / Issue

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: a. Model No. 781196; UDI-DI N/A. b. Model No. 781343; UDI-DI 00884838055292. c. Model No. 781296; UDI-DI 00884838004108. All units are affected.
View official government recall

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