Recall Z-2127-2011 ยท OBO Tomography, Optical Coherence
Carl Zeiss Meditec Inc
Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded to, version v 1.0 - 4.5, 5.0.0 or 5.1.0 The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.
| Date | May 2, 2011 (initiated Mar 10, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| 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. |
| Quantity | 3465 US; 3423 OUS |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083291 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 Carl Zeiss Meditec, Inc., May 5, 2009 |