GE Healthcare, LLC recalls (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal…
Inaccurate Distance and Area measurements with use of Global Stack viewport.
Read the official notice →- Date
- 2022-08-31
- Country
- United States
- Brand
- GE Healthcare
- Product
- (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal…
- Classification
- Class II
- Units
- Distribution was made to AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-11-01
USGE Healthcare recalls Universal Viewer Workflow Manager, Image processing radiological system
When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and…
FDA · DeviceGE HealthcareNationwide distribution to AR, AZ, CA, CO, DE, FL, GA, IL, IN, ME, MI, MN, MO,…Official notice →- US
GE Healthcare recalls Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and…
FDA · DeviceGE HealthcareUS and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile,…Official notice → - 2023-05-10
- US
GE Healthcare recalls Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e)…
GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
- 2022-08-17
- US
GE Healthcare, LLC recalls Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite…
As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place…
FDA · DeviceGE Healthcare, LLCUS Nationwide distribution including PR. There was also government/military…Official notice → - 2022-08-03
- US
GE Healthcare, LLC recalls Centricity PACS Software Version 7.0 SP0.0.4.7
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
- US
GE Healthcare, LLC recalls SIGNA Premier magnetic resonance scanner, model 5748519.
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.
FDA · DeviceGE Healthcare, LLCWorldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice →
Other drugs & medical recalls in the United States
- 2022-08-31
- US
Materialise USA LLC recalls ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK
- US
Getinge Usa Sales Inc recalls Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric…
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be…
FDA · DeviceGetinge Usa Sales IncWorldwide distribution - US Nationwide and the countries of Australia (AU),…Official notice → - US
Wright Medical Technology, Inc. recalls Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
An incorrect sizing label was applied to the carton packaging.
FDA · DeviceWright Medical Technology, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
Nobel Biocare recalls Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
FDA · DeviceNobel BiocareU.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.:…Official notice → - US
bioMerieux, Inc. recalls NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
FDA · DevicebioMerieux, Inc.Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN,…Official notice → - US
DeRoyal Industries Inc recalls DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick…
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.Official notice →