Recall – Patient information mismatched in central topography system

Company: Carl Zeiss Meditec AG
Date of Enforcement Report: 2/24/2021
Class II

PRODUCT

IOLMaster 700

Recall Number: Z-1133-2021

REASON

When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen.

RECALLING FIRM/MANUFACTURER

Carl Zeiss Meditec AG on 12/7/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

613 devices

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.