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Flow-c Anesthesia System (Product Code 6887700) recallZ-0422-2023 · Getinge Usa Sales Inc · initiated Nov 7, 2022

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

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.

FDA root cause category: Component design/selection

What the company is doing

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).

Recall details

Recall number
Z-0422-2023
Status
Open, Classified
Initiated by the company
Nov 7, 2022
Posted by the FDA
Dec 7, 2022
Recalling firm
Getinge Usa Sales Inc
Quantity
65 US
Product code
BSZ
FDA submissions
K191027
Distribution
US Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.

Product description

Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)

Code information (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

4 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.

Sources and updates

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