Device product
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT
Z-2214-2021
Product summary
- Event
- Event 88199
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21 units
- Official record key
device-enforcement:Z-2214-2021
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: 110715076 110915596 110915597 111015378 111015411 110515348 110515556 110517101 110915707 110915708 110915743 111118747 111215214 111216659 111216660 111216671 110717082 110717084 140915228 150615371 100215401 UDI: 07613327278408
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