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Midas Rex Clearview
MEDTRONIC XOMED, INC. · Model SP14MH25 · UDI-DI 00763000892845
ERL
Prescription
1
510(k) clearances
29,783
Adverse events (4 deaths)
29
Recalls
133
Facilities
Description
TOOL DC SP14MH25 LGD 14CM PROX 2.5 MH
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-12-15 | Medtronic Xomed, Inc. | As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect |
| 2020-09-11 | Bien-Air Surgery Sa | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. |
| 2020-09-11 | Bien-Air Surgery Sa | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. |
| 2020-09-11 | Bien-Air Surgery Sa | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. |
| 2020-09-11 | Bien-Air Surgery Sa | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. |
| 2020-09-11 | Bien-Air Surgery Sa | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. |
| 2020-06-12 | Medtronic Xomed, Inc. | During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
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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.