The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and…"

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

See all →

Same hazard · loss of ventilation

See all →

Similar recalls