GE Healthcare, LLC recalls GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number…
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
Read the official notice →- Date
- 2022-07-27
- Country
- United States
- Brand
- GE Healthcare
- Product
- GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number…
- Classification
- Class I
- Units
- Worldwide Distribution. US nationwide, Australia, Austria, Belgium, Bolivia,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More GE Healthcare recalls
- 2022-08-03
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The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
FDA · DeviceGE Healthcare, LLCWorldwide distribution - US Nationwide distribution in the states of CO, NV,…Official notice →- 2022-07-27
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Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.
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GE Healthcare, LLC recalls GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.
FDA · DeviceGE Healthcare, LLCDistribution was made to AZ, CA, CO, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD,…Official notice → - 2022-07-13
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GE Healthcare, LLC recalls GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer…
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GE Healthcare, LLC recalls Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Backup batteries can fail earlier than their estimated life.
FDA · DeviceGE Healthcare, LLCWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2022-06-22
- US
GE Healthcare, LLC recalls CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part…
The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.
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Other drugs & medical recalls in the United States
- 2022-07-27
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Boston Scientific Corporation recalls GreenLight HPSEA Laser Fibers, UPN 0010-2092
Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and…
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Aesculap Implant Systems LLC recalls ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic…
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA,…Official notice → - US
R & D Systems, Inc. recalls Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations…
The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is followed by the Notified Body…
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Hobbs Medical, Inc. recalls Hobbs Medical Polypectomy Snare, Catalog No. 7202
During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.
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SONEX HEALTH LLC recalls SX-One MicroKnife
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Stryker Neurovascular recalls Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413;…
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