GE Healthcare (China) Co., Ltd. recalls GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5)…
The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to…
Read the official notice →- Date
- 2024-09-04
- Country
- United States
- Brand
- GE Healthcare
- Product
- GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6)…
- Classification
- Class II
- Units
- Worldwide 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-10-02
USGE Healthcare recalls GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a…
- 2024-09-25
- US
GE Healthcare recalls GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d)…
Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a…
- US
GE Healthcare GmbH recalls ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA;…
The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing…
FDA · DeviceGE Healthcare GmbHUS Nationwide distribution including in the states of Alabama, Alaska,…Official notice → - 2023-11-01
- US
GE 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.
Other drugs & medical recalls in the United States
- 2024-09-04
- US
Abbott Diagnostics Technologies AS recalls Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.
FDA · DeviceAbbott Diagnostics Technologies ASUS Nationwide distribution in the states of AZ, IN, MA, MN, and OH.Official notice → - US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of CA, FL, GA, IN, KS,…Official notice → - US
Schiller, Ag recalls CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
FDA · DeviceSchiller, AgWorldwide - US distribution in the state of Florida and the countries of…Official notice → - US
Howmedica Osteonics Corp. recalls Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
FDA · DeviceHowmedica Osteonics Corp.International distribution to the country of Australia.Official notice → - US
Stryker Corporation recalls Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating,…
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure…
FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - US
Intuitive Surgical, Inc. recalls Ion Endoluminal System, REF: 380748-65
There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of AZ and CA.Official notice →