Recall Z-2212-2026 ยท FNL Bed, Ac-Powered Adjustable Hospital
KAYSERBETTEN GMBH & CO. KG
Pediatric care bed; Product Designation: KayserBett IDA;
| Date | Jun 4, 2026 (initiated May 4, 2026) |
| Status | Open, Classified |
| Reason | If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children). |
| Root cause | Device Design |
| Action | On May 4, 2026 Urgent Field Safety Notice letters were sent to customers. Actions to be taken: Please inform all users and operators of a KayserBett IDA that by implementing the following safety measures, the above-mentioned risk to patients or third parties can be eliminated during further use of the product. If the patient is unattended, " the sleeping platform must be lowered to its lowest position. " the adjustment functions on the hand control must be locked using a key. " the doors must be closed. KayserBetten is implementing a corrective action to replace the hand control on all affe |
| Quantity | 372 units |
| Distribution | Distribution US Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.