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FDA device recall Z-0395-2024 · posted 2023-11-21 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

Potential component failure in the Gradient Coil could product smoke and/or fire.

Action taken

The firm mailed URGENT Medical Device Correction Notices dated 10/23/2023 to consignees to notify them of this recall event. Consignees are instructed to identify if they possess any affected devices in their inventory and to follow the provided instructions for when scan aborts occur to prevent the failure mode associated with this recall event. Consignees are to stop the scan immediately and contact Philips Service if any of the failure situations outlined in the notice occur during a scan. Consignees are asked to complete and return the provided response form to Philips no later than 30 days after receipt of the recall notice. Questions can be directed to Customer Care Solutions at 1-800-722-9377.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LNH

Quantity affected

119 units

Distribution

Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denm

Date initiated

2023-10-23

Date posted

2023-11-21

Location

Cambridge, MA