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Philips North America Recall 93787

Description: Intera 1.5T Achieva Nova, Model (REF) Numbers 781172

Philips North America Recall 93787 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0952-2024
Event ID93787
Event DescriptionIntera 1.5T Achieva Nova, Model (REF) Numbers 781172
Product TypeDevices
DistributionWorldwide - US Nationwide distribution.
Quantity15 US; 68 OUS
Recall ReasonThe 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.
Device Classification20240207
Device Code InfoModel No. 781172 UDI-DI N/A All units affected
Center Classification Date20240201
Recall Initiation Date20240103
Recalling FirmPhilips North America
Initial Notification Letter
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