Z-0477-2022Class II

OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4

Name: Z-0477-2022 OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Creator: Haag-Streit USA Inc
Published: 2021-11-03
License: https://open.fda.gov/license/

Haag-Streit USA Inc / initiated 2021-11-03 / Open, Classified / root cause: software

FDA source

Haag-Streit USA Inc began a recall of OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 on 2021-11-03. FDA classified it as Class II and gives the reason as "Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0477-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-03
Posted: 2022-01-10
Recalling firm: Haag-Streit USA Inc
Product: OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Product code: HLI Ophthalmoscope, Ac-Powered
Reason for recall: Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Root cause tag: software
FDA 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: [email protected] for questions concerning this procedure.
Quantity in commerce: 2 devices quarantined in US
Distribution: US Nationwide distribution in the states of OH, IN.
Product codes and lots: Serial no. 0005, 0023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0477-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0477-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-19	2022-01-10
Z-0478-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-19	2022-01-10

Product code HLI

K142953Class IIOCT-CameraOptomedical Technologies GmbH / cleared 2015-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)