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Open, Classified

dS Breast 16ch 1.5T

FDA Recall Z-0537-2025 · Posted 2024-11-25

Recalling FirmPhilips North America Llc
Recall StatusOpen, Classified
Product CodeMOS
Date Initiated2024-11-04
Product Quantity5,231 units

Reason for Recall

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Firm Action

An URGENT MEDICAL DEVICE CORRECTION notice dated 10/31/24 was mailed to consignees. Consignees are to continue using affected systems in accordance with the intended use. When using the system follow section PRECAUTIONS, CAUTIONS & WARNINGS in the Instructions For Use (IFU). Consignees are to circulate the recall notice to all users for their awareness of the potential issue. The Recall Response Form is to be provided back to Philips MR within 30 days at [email protected]. Customers with any questions are to contact their local Philips Representative.

Root Cause

Use error

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072873LBS-63-16 BREAST ARRAY COILInvivo · 2007-11-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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