Recall Z-0838-2025 ยท IKX Aid, Transfer
NOA Medical Industries Inc
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
| Date | Jan 10, 2025 (initiated Nov 5, 2024) |
| Status | Open, Classified |
| Reason | Red button used to engage side rails can break or become stuck making it difficult to engage the side rail. |
| Root cause | Device Design |
| Action | NOA Medical Industries issued an URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION notice to its consignees on 11/05/2024 via email. The notice explained the problem with the device, potential risk, and temporary actions to employ to minimize the hazard until a replacement frame is installed. A replacement side rail will be provided. For questions or concerns, contact: support@noamedical.com (email), https://www.noamedical.com/ (website) or 1-636-239-7600 (telephone), Monday-Friday 7:00AM to 3:30PM, CT. |
| Quantity | 34 units |
| Distribution | US: GA, MI. MA, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.