Haag Streit Surgical Floor stands FS 2-11 recall: Software Issue
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO…
Why was Haag Streit Surgical Floor stands FS 2-11 recalled?
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
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?
Floor stands FS 2-11, FS 2-15 with the software REF 615 588 in versions 2.0 to 3.3. FS 2-11 Ref. # 615H511 Serial Numbers:From 1001; FS 2-15 Ref. #615H515 Serial Numbers From 1001; HS Hi-R NEO 900 Ref. # 657 Serial Numbers 820 from 101; HS Hi-R NEO 900A Ref # 657 821 Serial Numbers from 101 Unique Device Identifier (UDI) HS Hi-R NEO 900 +EMWM657 820 0/$+serial no. HS Hi-R NEO 900A +EMWM657 821 0/$+serial no. FS 2 11 +EMWM 615H5110/$+serial no. FS 2-15 +EMWM 615H515 0/$+serial no.
- Product
- Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO…
- Recalling firm
- Haag-Streit USA Inc
- Quantity
- 3 units US
- Distribution
- US Nationwide distribution in the state of OK.
- Recall date
- December 30, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)