OCT-Camera 211 01 A3 recall
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Why was OCT-Camera 211 01 A3 recalled?
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial no. 0157, 0158 & 0171
- Product
- OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
- Recalling firm
- Haag-Streit USA Inc
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of OH, IN.
- Recall date
- January 19, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)