🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
All Recalls
95,089 total recalls in our database
SmartPath to dStream for 1.5T, Model No. 781260, 782112
Philips North America
🏥 Medical Devices Class I - Dangerous
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
🏥 Medical Devices Class I - Dangerous
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Intera 1.5T, Model No. 781195
Philips North America
🏥 Medical Devices Class I - Dangerous
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
🏥 Medical Devices Class I - Dangerous
Sterility of Ultrasound gel can not be guaranteed.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
🏥 Medical Devices Class I - Dangerous
DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.
Achieva 1.5T, Model No. 781178, 781196, 781296
Philips North America
🏥 Medical Devices Class I - Dangerous
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
🏥 Medical Devices Class I - Dangerous
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
🏥 Medical Devices Class I - Dangerous
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
REV 2 Flowcell Capsule Spare, Part Number: C04154
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Achieva 1.5T Conversion, Model No. 781283
Philips North America
🏥 Medical Devices Class I - Dangerous
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Ingenia Ambition X, Model No. 782109
Philips North America
🏥 Medical Devices Class I - Dangerous
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Snapshot NIR, REF: KD204
KENT IMAGING
🏥 Medical Devices Class I - Dangerous
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Accure Laser System, Model: PFMS00004
Accure Acne
🏥 Medical Devices Class I - Dangerous
Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.