The Recall Desk
HighFDA (Devices)·Z-0579-2018·Announced 2018-02-21

GE Carestation 600 Series Recalled for Possible Incomplete CO2 Seal

GE Medical Systems is recalling 5,148 Carestation 600 Series anesthesia machines due to a possible incomplete seal between the CO2 absorber and the breathing circuit.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential mechanical defect in an anesthesia machine that could affect patient safety, but no specific injuries or illnesses are reported in the source text, placing it in the 'High' category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Medical Systems China Co., Ltd. is recalling 5,148 Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 anesthesia machines. The recall is due to a possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly.

The affected devices were distributed domestically to 37 U.S. states and the District of Columbia, as well as internationally to numerous countries including Canada, the United Kingdom, Germany, and Japan. The recall covers specific model numbers and serial numbers listed in the official FDA notice.

Healthcare facilities should check their inventory for the affected serial numbers and contact GE Medical Systems for further instructions on corrective actions. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Manufacturer
GE Medical Systems China Co., Ltd.
Category
Medical Device — Anesthesia Machine
Hazard
Affected units
5,148

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Model No. 1012-9620-000
  • 1012-9650-000
  • 1012-9655-000
  • 1012-9650-002
  • 1012-9620-002
  • 1012-9655-002

Distribution

Distributed in 39 states:

Part of a larger recall action

This product is one of 2 recalled by GE Medical Systems China Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems China Co., Ltd.

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Same hazard · mechanical defect

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