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Karl Storz GmbH & Co. KG · Model 40160032 · UDI-DI 04048551242483
EQL
Prescription
8
510(k) clearances
149
Adverse events
2
Recalls
35
Facilities
Description
One-Pedal Footswitch
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-12-12 | Pentax of America Inc | Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108. |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
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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.