Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Bard Peripheral Vascular
Class I - Dangerous
Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Class I - Dangerous
Reports that the T-piece does not fit on the nebulizer.
Class I - Dangerous
The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.
Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult. If the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone.
Class I - Dangerous
The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
Class I - Dangerous
Damage to package seals potentially compromising sterility.
ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
Global Healthcare
Class I - Dangerous
Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Radiometer America
Class I - Dangerous
The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Philips Medical Systems
Class I - Dangerous
In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.
Fuse 1C Colonoscope
EndoChoice
Class I - Dangerous
The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.
Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Fresenius Medical Care Renal Therapies Group
Class I - Dangerous
The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).
Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
Globalmed Logistix
Class I - Dangerous
The cannulae may bend during procedure.
Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.
Valeant Pharmacueticals International
Class I - Dangerous
The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
Iba Dosimetry Gmbh
Class I - Dangerous
When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner.
Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.