Maquet Critical Care AB/Getinge Servo-u Ventilator System — Class I medical device recall Z-1560-2022
Ongoing recall by Getinge Usa Sales Inc, reported 2022-08-31, distributed nationwide. Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms b
| Recall number | Z-1560-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Usa Sales Inc, Wayne, NJ, United States |
| Recall initiated | 2022-07-20 |
| Classified | 2022-08-22 |
| Reported by FDA | 2022-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UA, UY, VN, ZA |
| Serial numbers | 188, 190, 192, 193, 194, 196, 197, 198, 199, 201, 205, 206, 210, 212, 213, 214, 215, 216, 217, 21702, 21703, 21704, 21705, 21706, 21707 and 475 more |
| Model numbers | 6688600, 6694800, 6882000, 6888800 |
Product
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
Reason for recall
Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to hypoventilation and consequently desaturation, with patient outcomes including hypoxemia and hypoxic injury, which might result in circulatory failure.
Machine access
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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.