Device product
IVEA 500A Intended for Med-Surg patient care.
Z-0767-2017
Product summary
- Event
- Event 75571
- Status
- Terminated
- Classification
- Class II
- Quantity
- 239
- Official record key
device-enforcement:Z-0767-2017
Official wording
Reason: The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.
Code information: Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.
Distribution pattern: Worldwide Distribution -- USA and Canada.
Derived failure modes
-
Unknown
The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.