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BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 4...

FDA Recall #Z-0930-2024 — Class I — December 15, 2023

Recall #Z-0930-2024 Date: December 15, 2023 Classification: Class I Status: Ongoing

Product Description

BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;

Reason for Recall

Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.

Recalling Firm

Philips North America — Cambridge, MA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

56 US; 46 OUS

Distribution

Domestic distribution nationwide. International distribution worldwide.

Code Information

All serial numbers are affected. No UDI-DI available for this product.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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