Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
This recall has been terminated (originally issued June 23, 2022).
- Company
- Getinge Usa Sales Inc
- Recall Initiated
- May 2, 2022
- Posted
- June 23, 2022
- Terminated
- August 6, 2024
- Recall Number
- Z-1279-2022
- Quantity
- 47 units US
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
Lot / Code Info
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)
Root Cause
Component design/selection
Action Taken
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 actflow-ce.us@getinge.com 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.