GE Medical Systems, LLC recalls GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB;…
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and…
Read the official notice →- Date
- 2025-01-15
- Country
- United States
- Brand
- GE Medical Systems
- Product
- GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB;…
- Classification
- Class II
- Units
- Worldwide
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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USGE Medical Systems, LLC recalls Optima XR646 HD. X-Ray imaging system.
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still…
FDA · DeviceGE Medical Systems, LLCWorldwide Distribution: US (nationwide) including Puerto Rico and OUS…Official notice →- 2025-01-22
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There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.
FDA · DeviceGE Medical Systems, LLCWorldwide - US Nationwide distribution in the states of OH, TX and the…Official notice → - 2025-01-15
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GE Medical Systems, LLC recalls Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- 2024-12-04
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GE Medical Systems, LLC recalls SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
FDA · DeviceGE Medical Systems, LLCWorldwide Distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice → - 2024-08-14
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GE Medical Systems, LLC recalls SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D…
- 2022-12-28
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GE Medical Systems, LLC recalls Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes,…
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
FDA · DeviceGE Medical Systems, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
Other drugs & medical recalls in the United States
- 2025-01-15
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Nipro Renal Soultions USA, Corporation recalls Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
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Applied Medical Technology Inc recalls AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit…
FDA · DeviceApplied Medical Technology IncUS Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH,…Official notice → - US
GE Medical Systems, LLC recalls Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
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Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If…
FDA · DeviceSpacelabs Healthcare, Inc.US: MN, TX, TN, SC, OK, NM, GA, PA, OH, IA, AL, CO, AR, FL, MO, ME, LA, IL,…Official notice → - US
Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If…
FDA · DeviceSpacelabs Healthcare, Inc.US: OK, MN, IA, SC, NE, MI, NY, KY, GA, MO, MT, LA, WA, SD, CO, PA, WY, TX,…Official notice → - US
Aerin Medical, Inc. recalls Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.
FDA · DeviceAerin Medical, Inc.US Nationwide Distribution: AL, AZ, CA, CO, GA, ID, IL, IN, KY LA, MI, MN, NY,…Official notice →