GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Summary
The FDA issued a Class I for GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field R by GE Medical Systems China Co., Ltd.. Reason: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power i.
Details
Source
Device Recall
External ID
Z-0915-2026
Action Date
2025-12-24
Status
Ongoing
Category
device
Product Description
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Lot/Code Info: FRU 2076139-001-S, distributed between June 2, 2025 and October 21, 2025
Quantity Affected: 203 units
Reason for Recall
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, China, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lithuania, Malaysia, Mexico, Moldova, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Vietnam.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-14
Company
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 208 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems China Co., Ltd. has 22 FDA actions in our database, including 22 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems China Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems China Co., Ltd. have FDA actions?
GE Medical Systems China Co., Ltd. has 22 FDA actions in our database, including 22 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0915-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29