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CARILEX MEDICAL, INC. · Model S2204-A060 · UDI-DI 04713616092715
10
510(k) clearances
172
Adverse events (4 deaths)
1
Recalls
130
Facilities
Description
Relief Cushion Cover 16 x 20" TDX H&R-1p
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-03-20 | Roho Inc. | When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. Sitt |
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