Intera CV, Magnetic Resonance System.
FDA device recall Z-1586-2024 · posted 2024-04-17 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- Patient support table floor plate may be incorrectly installed.
- Action taken
- 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 pd.cnr@philips.com.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- LNH
- Quantity affected
- 8 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovi
- Date initiated
- 2024-03-12
- Date posted
- 2024-04-17
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K193215) | Philips Medical Systems Nederland B.V. | 2020-04-10 |