Terminated

Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version 4.6 or 5.1.0 software. The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.

FDA Recall Z-2126-2011 · Posted 2011-05-02

Recalling FirmCarl Zeiss Meditec Inc

Recall StatusTerminated

Product CodeOBO

Date Initiated2011-03-10

Date Terminated2012-03-29

Product Quantity3465 US, 3423 OUS

Reason for Recall

A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient

Firm Action

Carl Zeiss Meditec, Inc. sent an Field Correction Action letter dated March 9, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letters requested acknowledgement of the letter and a response and the fact that a follow up packet with revised software will be sent to all customers with V 5.0.0 or 5.1.0 software. For questions, please call 1-855-853-9461.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Boliva, Brazil, Canada, France, Chili, China, Columbia, Denmark, Ecuador,Germany, Great Britain, Greece, Guatemala, Hong Kong, India, Japan, Lebanon, Malaysia, Mexico, New Zealand, Pakistan, Peru, Singapore,South Korea, Spain, Sri Lanka, Taiwan, Uruguay and Venezuela

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083291CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000Carl Zeiss Meditec, Inc. · 2009-05-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.