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…
Read the official notice →- Date
- 2024-09-25
- Country
- United States
- Brand
- GE Healthcare
- Product
- ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA;…
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of Alabama, Alaska,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-10-16
USGE Healthcare recalls GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129;…
GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study…
- 2024-10-02
- US
GE 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…
- 2024-09-04
- US
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…
- 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 →
Other drugs & medical recalls in the United States
- 2024-09-25
- US
Cypress Medical Products LLC recalls General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal…
FDA · DeviceCypress Medical Products LLCUS Nationwide distribution in the states of CA, NV, NY.Official notice → - US
Medtronic Inc. recalls 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031,…
Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.
- US
Boston Scientific Corporation recalls VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
- US
B. Braun Medical, Inc. recalls AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.
- US
SEER MEDICAL PTY LTD recalls Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG)…
During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the…
FDA · DeviceSEER MEDICAL PTY LTDWorldwide - US Nationwide distribution in the states of MN, NY, PA and the…Official notice → - US
CareFusion 303, Inc. recalls Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
FDA · DeviceCareFusion 303, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice →