Ingenia 3.0T, Magnetic Resonance System.
Recall
- Recall Number
- Z-1566-2024
- Event Number
- 94233
- Firm
- Philips North America Llc
- FEI Number
- 3016618143
- Product Code
- LNH
- Status
- Open, Classified
- Root Cause
- Process design
- Initiated
- March 12, 2024
- Posted
- April 17, 2024
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289
Description
Ingenia 3.0T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Consignees were mailed an URGENT Medical Device Correction notice, dated 3/12/24. Consignees are instructed by the notice to identify affected systems, which can continue to be used with the provided instruction. 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. If the affected system has any unexpected movement or becomes unstable immediately stop use and contact your Philips representative for interim support. The recall notice is to be circulated to all users and the provided advisory displayed. Completed response forms are to be emailed to [email protected].
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1,509 units