Servo-I ventilator system CO2 analyzer — Class II medical device recall Z-1224-2015
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2015-03-11, distributed nationwide. A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models t
| Recall number | Z-1224-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2015-01-12 |
| Classified | 2015-02-27 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2017-05-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CL, CO, DE, EC, EG, ES, FI, FR, GB, HU, ID, IN, IQ, IS, IT, JP, NL, NO, PA, PE, PT, RO, RU, SA, SE, TH, TN, TR, UA, ZA |
| Quantity | 486 units |
| Serial numbers | 10003, 10004, 10005, 10006, 10007, 10008, 10009, 10010, 10011, 10012, 10013, 10018, 10019, 10020, 10021, 10022, 10023, 10024, 10027, 10029, 10032, 10060, 10064, 10070, 10078 and 177 more |
| Model numbers | 588 |
Product
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Reason for recall
A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1224-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.