CLASS II ONGOING Device recall · Reported 19 Jan 2022 · FDA Enforcement Report
OCT-Camera 211 01 A1, Running recalled by Haag-Streit USA
Haag-Streit USA is recalling OCT-Camera 211 01 A1, Running, distributed nationwide in the US. The recall was initiated on 3 Nov 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0477-2022
- FDA event ID
- 89176
- Recalling firm
- Haag-Streit USA, Mason, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Nov 2021
- FDA classified
- 10 Jan 2022
- Reported
- 19 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 3 Nov 2021 | Recall initiated by company | |
| 10 Jan 2022 | Classified by FDA | +68 days |
| 19 Jan 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Where it was distributed
US Nationwide distribution in the states of OH, IN.
Questions about this recall
Is OCT-Camera 211 01 A1, Running recalled?
Yes. Haag-Streit USA recalled OCT-Camera 211 01 A1, Running on 3 Nov 2021. The recall is Class II and its status is Ongoing. Recall number Z-0477-2022.
Why was it recalled?
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Which lots are affected?
Serial no. 0005, 0023
Where was it sold?
US Nationwide distribution in the states of OH, IN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Haag-Streit USA
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OCT-Camera 211 01 A3 recalled by Haag-Streit USA | Haag-Streit USA | Device Malfunction | Nationwide |
| Device | CLASS II | Eyesuite 9.3.1 software, Lenstar, Model LS900: ac-powered slit-lamp recalled | Haag-Streit USA | Device Malfunction | Nationwide |
| Device | CLASS II | Haag Streit Surgical Floor stands FS 2-11 recalled | Haag-Streit USA | Device Malfunction | Nationwide |
| Device | CLASS II | HS Hi-R NEO 900A Reference # recalled by Haag-Streit USA | Haag-Streit USA | Device Malfunction | OH |
| Device | CLASS II | HS Hi-R NEO 900 Reference # recalled by Haag-Streit USA | Haag-Streit USA | Device Malfunction | OH |
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