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McKesson

MCKESSON MEDICAL-SURGICAL INC. · Model 156-4PM3 · UDI-DI 10612479260419

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Premium GS 777 Integrated Wall System PANOPTIC PLUS | SURETEMP® PLUS

Recalls

Date	Firm	Reason
2021-11-03	Haag-Streit USA Inc	Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
2017-07-27	Optovue, Inc.	FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
2017-07-27	Optovue, Inc.	FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
2016-03-16	Optovue, Inc.	A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on
2013-05-14	Optovue, Inc.	Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individ
2009-07-31	Carl Zeiss Meditec Inc	Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly labels OD or OS.
2008-01-08	Keeler Instruments Inc	Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.

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Data 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.