GE Carestation 600 Series Recalled for Possible Incomplete CO2 Absorber Seal
GE Medical Systems is recalling Carestation 600 Series anesthesia machines due to a possible incomplete seal between the CO2 absorber and 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, which typically corresponds to a High severity score (3) in the absence of reported hospitalizations or injuries, representing a risk of harm where injury has not yet been reported.
Plain-English summary
GE Medical Systems China Co., Ltd. is recalling 5,148 units of the Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2 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 numerous US states and territories, as well as internationally to over 100 countries. The specific models involved are identified by model numbers 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, and 1012-9655-002.
Healthcare facilities and users should check their device serial numbers against the list provided in the official recall notice to determine if their equipment is affected. The 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 A2, Carestation 650 A2, and Carestation 650c A2
- Manufacturer
- GE Medical Systems China Co., Ltd.
- 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 (16)
- Model No. 1012-9620-000
- 1012-9650-000
- 1012-9655-000
- 1012-9650-002
- 1012-9620-002
- 1012-9655-002
- Serial No. SM617240023WA-A2
- UDI No.: 010084068210398521SM617250012WA11170624
- 010084068210398521SM617250003WA11170619
- 010084068210398521SM617250004WA11170619
- 010084068210398521SM617250010WA11170621
- 010084068210398521SM617250013WA11170624
- 010084068210394721SM717260002WA11170627
- 010084068210394721SM717260001WA11170627
- 010084068210395421SM817210001WA11170522
- 010084068210395421SM817210002WA11170522
Distribution
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
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