GE Healthcare, LLC recalls Revolution Apex, Revolution CT with Apex Edition
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
Read the official notice →- Date
- 2022-04-13
- Country
- United States
- Brand
- GE Healthcare
- Product
- Revolution Apex, Revolution CT with Apex Edition
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-04-27
USGE Healthcare, LLC recalls GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T,…
During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
FDA · DeviceGE Healthcare, LLCWorldwide Distribution: US (nationwide), including Puerto Rico and the U.S.…Official notice →- 2022-04-20
- US
GE Healthcare, LLC recalls MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
FDA · DeviceGE Healthcare, LLCUS and Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, England,…Official notice → - 2022-04-13
- US
GE Healthcare, LLC recalls Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
There is potential for the images to be flipped left to right.
FDA · DeviceGE Healthcare, LLCWorldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan,…Official notice → - 2022-03-23
- US
GE Healthcare, LLC recalls GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
FDA · DeviceGE Healthcare, LLCWorldwide distribution - US nationwide, including Puerto Rico. There was also…Official notice → - 2022-02-16
- US
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
FDA · DeviceGE Healthcare, LLCDistribution was nationwide, including Puerto Rico and the Virgin Islands.…Official notice → - 2022-02-02
- US
GE Healthcare, LLC recalls GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
FDA · DeviceGE Healthcare, LLCDomestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice →
Other drugs & medical recalls in the United States
- 2022-04-13
- US
Remote Diagnostic Technologies Ltd. recalls Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
FDA · DeviceRemote Diagnostic Technologies Ltd.US Nationwide distribution in the states of IL and KS.Official notice → - US
GE Healthcare, LLC recalls Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
There is potential for the images to be flipped left to right.
FDA · DeviceGE Healthcare, LLCWorldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan,…Official notice → - US
SA3, LLC recalls Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Due to failure of microbial testing for total aerobic microbial count (TAMC).
- US
Philips Healthcare recalls Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system,…
- US
Siemens Medical Solutions USA, Inc recalls YSIO X.Pree
For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide, Worldwide distributionOfficial notice → - US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box,…
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.