Recall Z-0478-2022 ยท OBO Tomography, Optical Coherence
Haag-Streit USA Inc
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
| Date | Nov 3, 2021 |
| Status | Open, Classified |
| Reason | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off |
| Root cause | Software design (manufacturing process) |
| Action | Haag-Streit USA send out field safety notice 2021-10/01 on November 03, 2021. Actions to be taken by the customer/user: Should one or more continuous straight lines be displayed on the screen of the OCT camera during an operation on the posterior segment of the patient's eye (see picture in the notification), the described risk possibly exists. 1. Switch off the OCT camera immediately (menu OCT -> Switch off). 2. The OCT camera is not permitted to be used any more. Please contact your responsible country representative. 3. Perform the software update of the OCT camera. You will receive the n |
| Quantity | 3 |
| Distribution | US Nationwide distribution in the states of OH, IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142953 | OCT-Camera Optomedical Technologies GmbH, Mar 4, 2015 |