[pending] Pediatric care bed; Product Designation: KayserBett IDA;
Pending LLM rewrite. Source: FDA_DEVICE Z-2212-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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).
The recalled product
- Product
- Pediatric care bed; Product Designation: KayserBett IDA;
- Manufacturer
- KAYSERBETTEN GMBH & CO. KG
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Designation: KayserBett IDA
- UDI-DI: 426038961IDAGU
- Serial Number: 386
- 387
- 388
- 389
- 390
- 391
- 392
- 635
- 636
- 637
- 638
- 639
- 641
- 642
- 643
- 644
- 645
- 646
Distribution
Distributed nationwide across the United States.
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