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Recall Observatory FDA recall evidence

Device product

Achieva 1.5T Initial system. Model (REF) Numbers 781178.

Z-0947-2024

January 03, 2024

Class II

Product summary

Firm
Philips North America
Event
Event 93787
Status
Ongoing
Classification
Class II
Quantity
23 US; 51 OUS
Official record key
device-enforcement:Z-0947-2024

Official wording

Reason: 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.

Code information: Model No. 781346 UDI-DI N/A All units affected

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.