Haag-Streit Surgical Floor Stands Recalled for Software Error
Haag-Streit USA Inc. is recalling surgical floor stands and operating microscopes due to a software error that may cause focusing movement to continue after the footswitch is released.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential injury to the patient's eye) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Haag-Streit USA Inc. is recalling the Surgical Floor stands FS 2-11 and FS 2-15 in combination with the operating microscopes HS Hi-R NEO 900 and HS Hi-R NEO 900A. The recall involves units equipped with software REF 615 588 versions 2.0 to 3.3. The products are used in ophthalmology and other disciplines with a vertical direction of view.
The recall is due to a software error where the movement of the focusing mechanism, triggered by pressing the footswitch button, might not stop when the button is released. This malfunction results in a potential risk to the patient's eye.
The recall affects 3 units distributed nationwide in the state of Oklahoma. Affected units include specific serial numbers for the floor stands and microscopes as detailed in the agency's structured product information. Consumers and healthcare facilities should contact the recalling firm for instructions on how to proceed.
The recalled product
- 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 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…
- Manufacturer
- Haag-Streit USA Inc
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Floor stands FS 2-11
- FS 2-15 Ref. #615H515 Serial Numbers From 1001
- HS Hi-R NEO 900 Ref. # 657 Serial Numbers 820 from 101
Distribution
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