FDANovember 15, 2012device
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.
What to do
FDA enforcement status: Terminated
Brands named
ge healthcare it
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAChlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-0...2026-06-05
- FDASiemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay2026-05-07
- CPSCBayer Recalls 6 mL Size Afrin Original Nasal Spray Bottles Due to Risk of Serious Injury or Illness from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging2026-04-30
- FDABrand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container.2026-04-22
- FDAepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;2026-04-02
- FDABrand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic para...2026-03-26
- FDAGE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.2026-03-24
- FDAGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.2026-03-24
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