Device product
Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE
Z-2222-2021
Product summary
- Event
- Event 88199
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-2222-2021
Official wording
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Code information: Serial Numbers: FL23J50576 FL23J50577 FL23J60424 FL23J60627 J32346 J32347 J32348 J32350 J29770 UDI: N/A
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Derived failure modes
-
Unknown
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals