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WHAT IS THIS?
A Recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
EVENT
| Type of Event | Recall |
|---|---|
| Recall Number | Multiple |
| Risk Class | Class 2 |
| Recall Qty | 10,104 |
| Classification Date | 2024-04-17 |
| Recall Link | Recall Link |
| Notes/Alerts | See below for the Field Service Notice for this Recall. |
| Recall Reason | Patient support table floor plate may be incorrectly installed. |
DEVICE
| Manufacturer | Philips North America Llc |
|---|---|
| Model Name | Various MRI Systems (41) |
| Model Number | Various Models (41) |
| Part/Item/Catalog/ REF/Product Number | - |
| Device Description | Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. |
| Serial Number(s) | Various SNs (10,104) |
| Lot #/Exp Date(s) | N/A |
CUSTOMER/PATIENT ACTIONS
1. Consignees were mailed an URGENT Medical Device Correction notice, dated 3/12/24.
2. Consignees are instructed by the notice to identify affected systems, which can continue to be used with the provided instruction.
3. If a patient’s weight is at or near the maximum load of the device take care that they do not sit on the end of the tabletop opposite the bore entrance and that they do not hop down from their sitting position while the support is at its highest position.
4. If the affected system has any unexpected movement or becomes unstable immediately stop use and contact your Philips representative for interim support.
5. The recall notice is to be circulated to all users and the provided advisory displayed. Completed response forms are to be emailed to pd.cnr@philips.com.
CONTACT INFORMATION
Report any adverse health consequences experienced with the use of this product to Philips. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via:
Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA 1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787