CLASS II Device recall · Reported 19 Aug 2020 · FDA Enforcement Report
Brainlab Curve; Model/catalogue (article) numbers for Curve recalled
Brainlab is recalling Brainlab Curve; Model/catalogue (article) numbers for Curve: 19901, distributed in California, Rhode Island, Texas. The recall was initiated on 16 Jul 2020 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-2792-2020
- FDA event ID
- 86046
- Recalling firm
- Brainlab, Munich, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2020
- FDA classified
- 13 Aug 2020
- Reported
- 19 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Jul 2020 | Recall initiated by company | |
| 13 Aug 2020 | Classified by FDA | +28 days |
| 19 Aug 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect manufacturer calibration
Product as listed by the FDA
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Where it was distributed
USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain
Questions about this recall
Why was it recalled?
Incorrect manufacturer calibration
Which lots are affected?
CURVE 1.1 DUAL NAVIGATION STATION, Serial Numbers: 3911619001-19901, S/N of affected NDI Camera: P7-21527 1173019001-19901B, S/N of affected NDI Camera: P7-21173 1444519001-19901B, S/N of affected NDI Camera: P7-21183 1937319001-19901B, S/N of affected NDI Camera: P7-21325 2201419001-19901B, S/N of affected NDI Camera: P7-21324 2456219001-19901B, S/N of affected NDI Camera: P7-21382 3524219001-19901B, S/N of affected NDI Camera: P7-21414 5379420001-19901B, S/N of affected NDI Camera: P7-21830 5609520001-19901B, S/N of affected NDI Camera: P7-21892 6968320001-19901B, S/N of affected NDI Camera: P7-20390 4593720001-19901B, S/N of affected NDI Camera: P7-21655 7850820001-19901B, S/N of affected NDI Camera : P7-22083 6393920001-19901B, S/N of affected NDI Camera: P7-21895 3844314001-19901B, S/N of affected NDI Camera: P7-21449 CURVE DUAL DISPLAY NAVIGATION STATION, Serial Numbers: 0824912001-19900, S/N of affected NDI Camera: P7-21890 3894613001-19900, S/N of affected NDI Camera: P7-21780 4387415001-19900, S/N of affected NDI Camera:P7-07290 CURVE SINGLE DISPLAY NAVIGATION STATION, Serial Number: 5762713001-19905, S/N of affected NDI Camera: P7-10719
Where was it sold?
USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 86046This product is part of a recall event; the main page for the event is Brainlab Kick 2; Model/catalogue (article) numbers for Kick recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Brainlab Kick 2; Model/catalogue (article) numbers for Kick recalled | Brainlab | Other | CA, RI, TX |
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