Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
PerkinElmer 226 Sample Collection Device
PerkinElmer Health Sciences
Class I - Dangerous
PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
AC Powered hospital adjustable bed.
Umano Medical
Class I - Dangerous
Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.
Class I - Dangerous
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Radiometer Medical ApS
Class I - Dangerous
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
Class I - Dangerous
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Class I - Dangerous
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays (Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
Class I - Dangerous
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Siemens Medical Solutions USA
Class I - Dangerous
Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient
safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
Radiometer Medical ApS
Class I - Dangerous
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
Class I - Dangerous
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Class I - Dangerous
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
System, Tomography Computed Emmission
GE Healthcare
Class I - Dangerous
GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
Radiometer Medical ApS
Class I - Dangerous
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
Class I - Dangerous
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Class I - Dangerous
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
Class I - Dangerous
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Olympus Corporation of the Americas
Class I - Dangerous
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.