Complete FDA and NHTSA recall records dated in August 2018.
These records include useful source details for the selected month.
General Motors LLC (GM) is recalling certain 2018-2019 Chevrolet Equinox, Impala, Cruze, Volt and Bolt EV vehicles, GMC Terrain vehicles, Buick Lacrosse and Regal vehicles, Cadillac XTS and…
Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having…
Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated…
Missing desiccant.
Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture.
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error…
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.
CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right…
Incomplete seal on the Tyvek lid may compromise the sterility of the device
Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be…
Premature strap wear and breakage at maximum weight conditions (625 lbs.).
CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right…
Order Status Remains Approved When Should Indicate Complete.
Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated…
Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.
Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be…
Premature strap wear and breakage at maximum weight conditions (625 lbs.).
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break without triggering the safety lock…
This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
