FDA Medical Device Recalls (openFDA)
Haag-Streit USA Inc: OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
- Recall number
- Z-0478-2022
- Recalling firm
- Haag-Streit USA Inc
- Product
- OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
- Status
- Open, Classified
- Initiated
- 2021-11-03
- Posted
- not on file
- Terminated
- not on file
- 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 new software version via your local representative, who will correct the error. 4. Please fill out and return the enclosed response form as soon as the software update has been performed 5. Please ensure that all users of the products mentioned are aware of and receive this urgent safety information. If you have passed the products to third parties, please forward a copy of this information and inform the contact person listed in the notification. 6. Software update organization will be performed by Haag-Streit USA, Inc. Please contact Mike Dietz at (513) 486-1513 or via email: fieldsafetynotice@haag-streit-usa.com for questions concerning this procedure.
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of OH, IN.
- Lot, serial or model codes
- Serial no. 0157, 0158 & 0171
- 510(k) numbers
- ["K142953"]
- PMA numbers
- not on file
- Product code
- OBO
- Firm FEI
- 1000136533
- Firm city
- Mason
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28