Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions for shared folders.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Pre-procedural issues related to software defects
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Carl Zeiss Metrology
Class I - Dangerous
Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user initiating x-ray generation from the control panel.
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Beaver-Visitec International
Class I - Dangerous
The protective shield was retracted, and the blade was exposed.
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Stryker Medical Division of Stryker
Class I - Dangerous
It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down).
Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM
Zimmer Biomet
Class I - Dangerous
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.