Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version 4.6 or 5.1.0 software. The Cirrus
FDA device recall Z-2126-2011 · posted 2011-05-02 · Terminated
Recall details
- Recalling firm
- Carl Zeiss Meditec Inc
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- OBO
- Quantity affected
- 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, U
- Date initiated
- 2011-03-10
- Date posted
- 2011-05-02
- Date terminated
- 2012-03-29
- Location
- Dublin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 (K083291) | Carl Zeiss Meditec, Inc. | 2009-05-05 |