Reported Dec 30, 2020 · Ongoing
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the…
Haag-Streit USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Haag-Streit USA Inc · 3535 Kings Mills Rd · Mason, OH · 45040-2303
Is this the product you have?
- 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 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 -
- Product Usageuse in ophthalmology and in other disciplines with vertical direction of view
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 615H511Floor stands FS 2-11, FS 2-15 with the software REF 615 588 in versions 2.0 to 3.3. FS 2-11 Serial Numbers:From 1001 615H515FS 2-15 Serial Numbers From 1001 657HS Hi-R NEO 900 Serial Numbers 820 from 101 657HS Hi-R NEO 900A 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. - Amount recalled
- 3 units US
Where it was sold
- Nationwide
- OK
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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