Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 30, 2020
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
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Haag-Streit USA Inc recalled Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515)… - a moderate-severity action.
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515)… was recalled by Haag-Streit USA Inc in December 30, 2020. Reason: Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing …. Check the official notice for the remedy. Verify recall #Z-0697-2021 with the FDA Devices before acting.
The recall
Haag-Streit USA Inc issued this moderate-severity FDA Devices recall-Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing ….
- Moderate
- severity level
- 3 units
- affected scope
- Class II
- classification
- December 30, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0697-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0697-2021) was formally reported on December 30, 2020, with the manufacturer initiating the action on November 20, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Haag-Streit USA Inc is listed as the recalling firm, operating out of Mason, OH. Federal records list the affected scope as 3 units US.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of OK.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3 units US
Related Recalls
6
3 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0697-2021 |
| Date reported | December 30, 2020 |
| Date initiated | November 20, 2020 |
| Recalling firm | Haag-Streit USA Inc |
| Firm location | Mason, OH |
| Affected scope | 3 units US |
| Distribution | US Nationwide distribution in the state of OK. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0697-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Haag-Streit USA Inc. Units affected: 3 units US.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0697-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of OK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0697-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 30, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.