Z-0697-2021 Class II Ongoing
FDA device recall Z-0697-2021 was initiated by Haag-Streit USA Inc on November 20, 2020 and is designated Class II. Reason for recall: 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 recall status is ongoing. Affected quantity: 3 units US.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 20, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units US
Product Description
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 Usage: use in ophthalmology and in other disciplines with vertical direction of view
Reason for Recall
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
Distribution Pattern
US Nationwide distribution in the state of OK.
Code Information
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.