FDA Medical Device Recalls (openFDA)
Getinge Usa Sales Inc: Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
- Recall number
- Z-0422-2023
- Recalling firm
- Getinge Usa Sales Inc
- Product
- Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
- Status
- Open, Classified
- Initiated
- 2022-11-07
- Posted
- 2022-12-07
- Terminated
- not on file
- Reason
- The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power failure. This could require the clinician to use manual emergency ventilation of another ventilator is not available and the backup battery is exhausted.
- Root cause
- Component design/selection
- Action
- On 11/7/22 the firm notified customers via Urgent Medical Device Correction letters. Customers were instructed to immediately identify whether they had affected Flow-c or Flow-e anesthesia systems on hand. Customers who have affected devices may continue to use the device ensuring that a system checkout procedure is performed per the Operators Manual. The firm will replace the Power backup battery free of charge for customers with affected anesthesia systems. You can also 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 the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
- Quantity
- 65 US
- Distribution
- US Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.
- Lot, serial or model codes
- Flow-c UDI-DI: 7325710010457 Lot/Serial Numbers 4003 4777 4783 5024 5025 5026 5027 5028 5043 5044 5045 5046 5047 5048 5049 5050 5078 Flow-e UDI-DI: 7325710009765 Lot/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
- 510(k) numbers
- ["K191027"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 3013876692
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28