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Regulated Software Application (RSA)
ARC-ONE SOLUTIONS, LLC · Model 1.0.33.0 · UDI-DI 00860003545409
MMH
Prescription
0
510(k) clearances
1,034
Adverse events (9 deaths)
2
Recalls
45
Facilities
Description
The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of the blood banking process.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-04-25 | ConvaTec, Inc | It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label. |
| 2010-06-22 | SCC Soft Computer | SCC Soft Computer is issuing a Correction for SoftBank II Versions: 23.1.2.x, 23.2.0.x, and 25.0.0.x software applications. Functionality issue - For clients generating patient hi |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.