Medical device recalls

Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.

Inadvertent shipment of expired units.

Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube

Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube

In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.

In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.

Device was marketed for uses outside the 510(k) clearance.

Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.

Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement

Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.

It was discovered that the product units it imported may, at peak levels, emit radiation that exceeds the federal standard for Class IIIa products.

Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit.

The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been selected using the VOI functionality and put into a fiber group. This is done with images series A visualized in the 3D viewer. Then a new images series B is visualized in the 3D viewer. If image series A and B have the same geometrical resolution (pixel sizes and slice distances), the coregistration matrix taking A to B will not be applied to the fiber group, and therefore the fiber group will in general not be positioned correctly on B in the 3D viewer. Furthermore, if the fiber group is exported as a new image series the fibers could be misplaced, and similarly if the fibers are visualized in the MPR on B, the positioning will not be correct. The misalignment will be equal to the rotations/translations necessary to align A with B.

An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.

Product sterility potentially compromised.

An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.

Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitization to latex and allergic reactions. Additional risks of powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue.

The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause therapy to be interrupted or delayed.

Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.

Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.

Product sterility may be compromised due to unsealed packaging.

Product sterility may be compromised due to unsealed packaging.