GE Medical Systems, LLC recalls Optima XR200amx, Mobile Digital-Ready Radiographic System
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly.…
Read the official notice →- Date
- 2026-07-22
- Country
- United States
- Brand
- GE Medical Systems
- Product
- Optima XR200amx, Mobile Digital-Ready Radiographic System
- Classification
- Class II
- Units
- Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Medical Systems recalls
- 2026-06-24
USGE Medical Systems, LLC recalls Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners…
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GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel…
- 2026-05-20
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GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution…
- 2026-04-01
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There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
- 2026-03-25
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There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized…
- 2025-12-17
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GE Medical Systems, LLC recalls Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
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Other drugs & medical recalls in the United States
- 2026-07-22
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Medline Industries, LP recalls Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant…
FDA · DeviceMedline Industries, LPUS Nationwide distribution in the states of CA and UT.Official notice → - US
Papablic Inc recalls Papablic Replacement Brush Heads. Model Number: PAPA317AA.
Potential for brush heads to break.
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Orthofix U.S. LLC recalls Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
FDA · DeviceOrthofix U.S. LLCUS: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA…Official notice → - US
Boston Scientific Corporation recalls Rapid Refill Continuous Injection System, UPN M00566001
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete…
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ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
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Intuitive Surgical, Inc. recalls da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result…
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