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Gimmi
Gimmi GmbH · Model CAM.4143.00 · UDI-DI 04049047788546
FET
Prescription
1
510(k) clearances
61,447
Adverse events (1 deaths)
8
Recalls
88
Facilities
Description
AlphaSMART Camera Head 4K NIR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-21 | Olympus Corporation of the Americas | It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met. |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo |
| 2018-05-11 | Olympus Corporation of the Americas | Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, m |
| 2018-05-11 | Olympus Corporation of the Americas | Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient |
| 2016-06-20 | Karl Storz Endoscopy | Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope and an electro-surger |
| 2015-06-30 | Fujifilm Medical Systems U.S.A., Inc. | The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales b |
| 2015-06-30 | Fujifilm Medical Systems U.S.A., Inc. | The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales b |
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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.