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MediChoice
Coopersurgical, Inc. · Model MC350R-SD8 · UDI-DI 00888937010237
MAA
Prescription
1
510(k) clearances
0
Adverse events
3
Recalls
1
Facilities
Description
MediChoice® Display Tabletop Doppler With Recharger And 8 MHz Vascular Probe
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2003-12-05 | Danatech Medical Systems Inc | This prescription device, without an approved 510K , was distributed to unauthorized consumers, mostly pregnant women, on the internet. |
| 2003-03-31 | Siemens Medical Solutions USA, Inc. | The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit. |
| 2003-03-31 | Siemens Medical Solutions USA, Inc. | The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit. |
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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.