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Accurian™
MEDTRONIC SOFAMOR DANEK, INC. · Model AGSW001 · UDI-DI 00763000405014
1
510(k) clearances
1,812
Adverse events (5 deaths)
7
Recalls
49
Facilities
Description
SFTWR KIT AGSW001 ACCURIAN GENRTR 1.1
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-28 | Abbott | Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capa |
| 2023-08-01 | Avanos Medical, Inc. | Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults. |
| 2021-04-22 | Abbott Laboratories Inc. (St Jude Medical) | Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emissio |
| 2019-10-14 | Abbott Medical | Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on |
| 2016-10-11 | Stryker Instruments Div. of Stryker Corporation | Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen Generator, because the instructions for use i |
| 2013-10-09 | Neurotherm, Inc. | NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in |
| 2010-04-13 | Stryker Instruments Div. of Stryker Corporation | This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of t |
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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.