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.
Read the official notice →- Date
- 2025-01-15
- Country
- United States
- Brand
- GE Medical Systems
- Product
- Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
- Classification
- Class II
- Units
- US Nationwide. Global 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Medical Systems recalls
- 2025-03-19
USGE Medical Systems, LLC recalls GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol)…
- 2025-02-12
- US
GE 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
- US
GE Medical Systems, LLC recalls Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring…
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
- US
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…
- 2024-12-04
- US
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
- US
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…
Other drugs & medical recalls in the United States
- 2025-01-15
- US
3B Medical, Inc. recalls Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product…
The devices were inadvertently shipped after their expiration date.
- US
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.
FDA · DeviceNipro Renal Soultions USA, CorporationUS distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.Official notice → - US
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 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…
- US
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 →