Invivo recallZ-0548-2025 · Philips North America Llc · initiated Nov 4, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential safety issue where a patient may be harmed while preparing for or during a scan.
FDA root cause category: Use error
What the company is doing
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.
Recall details
- Recall number
- Z-0548-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 4, 2024
- Posted by the FDA
- Nov 25, 2024
- Recalling firm
- Philips North America Llc
- Quantity
- 5,231 units
- Product code
- MOS
- FDA submissions
- K093284
- Distribution
- US Nationwide distribution.
Product description
ST SENSE Breast Dx Coil
Code information (models, lots, serial numbers)
REF: 453530264791; UDI-DI: 00884838066823; Serial No. 55, 3, 9, 36, 40, 56, 35, 39, 80, 46, 29, 7, 28, 55, 47, 54.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Invivo 45353026479Philips Ds North America LLC · Coil, magnetic resonance, specialty1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 95645).
- Z-0536-2025 · Open, ClassifiedAchieva TX Interventional Coil 3.0T
- Z-0537-2025 · Open, ClassifieddS Breast 16ch 1.5T
- Z-0538-2025 · Open, ClassifieddS Breast 16ch 3.0T
- Z-0539-2025 · Open, ClassifieddS Breast 7ch 1.5T
- Z-0540-2025 · Open, ClassifieddS Breast 7ch 3.0T
- Z-0541-2025 · Open, ClassifiedMammotrak Diagnostic Coil 1.5T
- Z-0542-2025 · Open, ClassifiedMammotrak Interventional Coil 1.5T
- Z-0543-2025 · Open, ClassifiedMammotrak Diagnostic Coil 3.0T
- Z-0544-2025 · Open, ClassifiedMammotrak Interventional Coil 3.0T
- Z-0545-2025 · Open, ClassifiedSENSE Breast Coil
- Z-0546-2025 · Open, ClassifiedSENSE Breast Coil 3.0T 7ch
- Z-0547-2025 · Open, ClassifiedST SENSE Breast Coil
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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