FDA Medical Device Recalls (openFDA)
Philips North America Llc: Mammotrak Interventional Coil 3.0T
- Recall number
- Z-0544-2025
- Recalling firm
- Philips North America Llc
- Product
- Mammotrak Interventional Coil 3.0T
- Status
- Open, Classified
- Initiated
- 2024-11-04
- Posted
- 2024-11-25
- Terminated
- not on file
- Reason
- Potential safety issue where a patient may be harmed while preparing for or during a scan.
- Root cause
- Use error
- 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 Philips.Recall@philips.com. Customers with any questions are to contact their local Philips Representative.
- Quantity
- 5,231 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- REF: 453530228891; UDI-DI: 00884838065857; Serial No. 73, 96, 58, 95, 119, 26, 16, 56, 94, 38, 28, 66, 135, 120, 2, 76.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MOS
- Firm FEI
- 3016618143
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28