Device product
Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710
Z-2218-2021
Product summary
- Event
- Event 88199
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2218-2021
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: G201170298 G201181816 G201318385 UDI: 07613327282436
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