Maquet Flow anesthesia machines recalled for vaporizer failure
Maquet Critical Care AB recalled certain Flow-i, Flow-c and Flow-e anesthesia machines after events were observed in which anesthetic agent was not delivered when the vaporizer was activated. The agency says this failure may result in a patient receiving insufficient anesthesia and may lead to intraoperative awareness. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Maquet recalls
What to do
- Contact Maquet Critical Care AB and your care team before changing how you use affected machines; the notice does not specify a remedy.
- Identify affected machines by model number: Flow-i C20 6677200, C30 6677300, C40 6677400, C20 6888520, C30 6888530, C40 6888540; Flow-c 6887700; Flow-e 6887900.
- Check the software version. The recall covers software versions 4.8, 4.10 and 4.11.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 408 US; 11,342 OUS
- Illnesses reported
- None reported
- Manufactured in
- Rontgenvagen 2, Solna, Sweden
- Classification
- Class II
- Recall number
- Z-2860-2026
In the FDA's words
- Description
- Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900 Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness. Flow-i C20 6677200 / UDI-DI 07325710001349 Flow-i C30 6677300 / UDI-DI 07325710001363 Flow-i C40 6677400 / UDI-DI 07325710001318 Flow-i C20 6888520 / UDI-DI 07325710010617 Flow-i C30 6888530 / UDI-DI 07325710010624 Flow-i C40 6888540 / UDI-DI 07325710010631 Flow-c 6887700 / UDI-DI 07325710009765 Flow-e 6887900 / UDI-DI 07325710010457 Software versions 4.8, 4.10, and 4.11. Distribution: Worldwide - US Nationwide distribution to the states of AL, AR, CA, CO, DC, DE, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, SC, TX, VA, WA, WV. Affected quantity: 408 US; 11,342 OUS
- Hazard
- Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.
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