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All product recalls affecting Texas.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Texas in the distribution area.
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 FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
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 FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
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 FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
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 FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
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 FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
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 FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
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 FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
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 FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module. Customers affected by this issue may observe an increase in reagent carousel motion errors or QSMC errors that occur while unloading or loading reagent packs during system initialization and sample processing, which causes a non-operational system status and cancels tests; and patient results may be delayed if these errors cancel test processing.
This recall involves Amana, Daikin, and Goodman branded packaged air conditioners and heat pumps. The recalled units are gray or green in color, and can be identified by the model number located on the electrical connection side of the unit on the outside panel. To see if your product is subject to this recall, visit www.goodmanmfg.com/package-recall.
Altec Industries, Inc. (Altec) is recalling certain 2023-2024 aerial devices, digger diggers, pressure diggers, service trucks, reel lifters, pressure washers, and articulating crane models built on a Freightliner M2 Plus chassis. Please refer to Altec's recall report for specific vehicle make and model details. The lighting wire harness may be overloaded, preventing the vehicle lighting from illuminating. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 108, "Lamps, Reflective Devices, and Associated Equipment."
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.
Terex South Dakota, Inc. (Terex) is recalling certain 2022-2023 TM vehicles. The master leveling controller may lose the ability to level the platform if power is lost while squeezing the enable trigger.
Airstream, Inc. (Airstream) is recalling certain 2024 Interstate motorhomes. The 12-volt in-line fuse that provides back-up power to the water heater/furnace system was not installed.
Jayco, Inc. (Jayco) is recalling certain 2024 Jay Feather travel trailers. A14-inch spare tire was mistakenly installed when the tire placard information is based on a 15-inch tire. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 110, "Tire Selection and Rims."
The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
Chrysler (FCA US, LLC) is recalling certain 2023 Jeep Grand Cherokee vehicles. A bolt for the second-row seat belt buckle may not be tightened properly. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 210, "Seat Belt Assembly Anchorages."
This recall involves Neve Strap Crampons and Accessory Kits, Style No. 400073, with date codes 01-2021, 05-2022, 07-2023, 01-2024 and SS1271. The date codes are located on the rubber heel strap pull-tab and on the underside of the toe piece under the anti-balling plate. The products are made of aluminum plates with spikes that attach to boots for ice climbing. The metal plates have a bright green color, and a black plastic toe and heel bail with a black webbing strap that fastens around the ankle. This recall also includes the Neve Strap Binding Accessory Kit, Style No. 400683, and Neve Strap Heel Cup Screw & Nuts, Style No. 400687, which were sold separately as spare parts/accessories.
This recall involves magnetic chess games with 20 magnet stones that are small, spherical, loose, and separable with a strong magnetic flux. The games are sold in a blue box with the words "Magnetic", "Magnetism", or "Magnetism Intelligence Strategy Game" on the front of the box. The game includes about 20 loose magnets, a string, a plastic storage tray with sponge lining, and instructions for play.