The Recall Desk
HighFDA (Devices)·Z-0814-2020·Announced 2020-01-29

GE Healthcare Recalls Carestation Anesthesia Systems Due to Loose Cable Risk

GE Healthcare is recalling 280 Carestation anesthesia systems worldwide due to a potential loose cable connection that could cause a loss of mechanical ventilation.

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 involves a medical device with a potential for serious harm (hypoxia) due to loss of ventilation, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 280 units of Carestation 620, 650, and 650c A2 anesthesia systems. These devices are intended to provide general inhalation anesthesia and ventilatory support to pediatric and adult patients. The recall covers units distributed in the United States and numerous countries worldwide, including Canada, the United Kingdom, Australia, and various nations in Europe, Asia, and the Americas.

The recall is being issued because GE Healthcare has identified a potential for a loose cable connection inside specific manufactured devices. This defect could result in a loss of mechanical ventilation. If this occurs, the system is designed to provide high-priority audio and visual alarms. However, the loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.

Healthcare facilities and consumers who possess these specific serial numbers should contact GE Healthcare for further instructions on how to address the defect. The affected units are identified by specific model numbers and serial numbers listed in the official recall documentation.

The recalled product

Product
Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia Systems
Hazard
Affected units
280

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)

  • CARESTATION 620 A2
  • Model number 1012-9620-002
  • No UDI
  • Model Number 1012-9650-002
  • Model Number 1012-9655-002
  • OUS only Mfg. Lot or Serial # SM818370001WA SM818480001WA SM818480005WA

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare, LLC 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 Healthcare, LLC

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Same hazard · loss of ventilation

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