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Other Medical Devices

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Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").

Merit Medical Systems

Class I - Dangerous

Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit labeling.

Apr 14, 2014 Other Medical Devices Nationwide View Details →

LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers.

Hospira

Class I - Dangerous

Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL.

Feb 25, 2014 Other Medical Devices View Details →

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

Varian Medical Systems

Class I - Dangerous

Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.

Mar 20, 2014 Other Medical Devices View Details →

AXIOM Vertix MD Trauma systems radiographic X-ray

Siemens Medical Solutions USA

Class I - Dangerous

There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety lock, which can result in the U-arm dropping down unexpectedly during movement in vertical direction, potentially causing serious injury.

Mar 5, 2014 Other Medical Devices View Details →
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