The FLOW-i Anesthesia System Axillary O2 and Suction Module — Class II medical device recall Z-2083-2015
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2015-07-22, distributed nationwide. Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning f
| Recall number | Z-2083-2015 |
|---|---|
| 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 | 2015-03-02 |
| Classified | 2015-07-15 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2016-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CH, CN, CO, CZ, DE, EC, ES, FI, FR, HK, HR, IL, IN, JP, KR, MX, NL, PE, PL, PT, RO, RS, RU, SE, SG, TH, TW, ZA |
| Quantity | 104 units |
| Serial numbers | 138, 14-24, 199, 205, 26-29, 367, 369-372, 391, 394-395, 416, 466-491, 517, 519, 525, 567-568, 570, 582-583, 606, 613, 619, 627, 629-631, 633, 635-641, 643-665 |
| Model numbers | 847 |
Product
The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.The system is intended for use in a wide range of population: from neonatal to adult patients. The system is intended for use in hospital environments, except for the MRI environment, by healthcare professionals trained in inhalation anesthesia administration. Auxiliary O2 and Suction Module: Is an option available for the FLOW-i Anesthesia System. The module contains two main parts: Flowmeter unit: The intended use of the flowmeter is to provide oxygen for patient therapy. Suction unit: The intended use is to extract body fluids from the stomach and airways.
Reason for recall
Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of suctioning capability of the modules.
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.