Flow-e Anesthesia System : Intended for use in… recallZ-1279-2022 · Getinge Usa Sales Inc · initiated May 2, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Getinge Usa Sales Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
FDA root cause category: Component design/selection
What the company is doing
Maquet Critical Care AB/Getinge initiated a voluntary Medical Device Correction Letter on 5/2/22. . Examine your inventory immediately to determine if you have any of the Flow-c and/or Flow-e anesthesia system(s) with the serial numbers as listed in this notice. . You may continue use of the affected device ensuring that the recommended daily system check out (SCO) and pre-anesthesia checkout procedures are followed as listed in the Operators Manual. . Check for functionality of the suction unit. If you detect a cracked or broken on/off switch before starting a new case, the anesthesia machine should be replaced with a fully functioning anesthesia machine or you should ensure that a temporary alternative suction substitution is available. . Customers with affected system(s) will be contacted by a Getinge Service Representative to schedule on-site correction of your device. You can arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9GETUSA / (888) 943 8872 (select option 1, then option 2), Monday through Friday, between 8 am and 6 pm (Eastern Time Zone). Whether you have affected product or not, please complete and sign the attached MEDICAL DEVICE Correction - RESPONSE FORM to acknowledge receipt of this notification. Return the completed form to Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to (877) 548-4901. Action by the Getinge: Maquet Critical Care AB/Getinge has identified the cause of the issue. A solution that will correct this issue has been developed and your unit will be corrected at no cost to you by replacing the on/off switch with a new, more durable one.
Recall details
- Recall number
- Z-1279-2022
- Status
- Terminated
- Initiated by the company
- May 2, 2022
- Posted by the FDA
- Jun 23, 2022
- Recalling firm
- Getinge Usa Sales Inc
- Quantity
- 47 units US
- Product code
- BSZ
- FDA submissions
- K191027
- Distribution
- US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
Product description
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
Code information (models, lots, serial numbers)
UDI-DI: 07325710010457 Serial Numbers: 50012, 50013, 50014, 50015, 50016, 50017, 50030, 50031, 50033, 50034, 50035, 50036, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50046, 50047, 50048, 50051, 50052, 50053, 50054, 50055, 50056, 50057, 50058, 50059, 50060, 50061, 50062, 50069, 50070, 50071, 50072, 50073, 50074, 50084, 50085, 50086, 50087, 50088, 50089, 50090, 50091, 50092, 50093, 50094, 50096, 50097, 50108, 50109, 50110, 50111, 50132. (Note: UDI was corrected July 7, 2022)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Flow-e Anesthesia System 6887900Maquet Critical Care AB · Gas-Machine, Anesthesia5 recalls19 reports
Other devices under the same FDA submission
5 devices cleared under K191027 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Flow-c Anesthesia System 6887700Maquet Critical Care AB · Gas-Machine, Anesthesia6 recalls72 reports
- Flow-i C20 Anesthesia System 6888520Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall2 deaths88 reports
- Flow-i C30 Anesthesia System 6888530Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall13 reports
- Flow-i C40 Anesthesia System 6888540Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall9 reports
- Vaporizer Sevoflurane, MAQUET filling 6886601Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90250).
- Z-1278-2022 · TerminatedFlow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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