Wisconsin Recalls

GE OEC Medical Systems, Inc recalls The OEC 9900 Elite mobile fluoroscopy system is designed to

GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

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Stryker Sustainability Solutions recalls Reprocessed Electrophysiology Catheter Cables Catalog Numbe

A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.

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J&J Solutions, Inc. DBA Corvida Medical recalls Halo Closed System Transfer Device, closed syringe adaptor,

Product malfunction: Needle does not retract.

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Stryker Sustainability Solutions recalls Reprocessed Ablation Catheter Cable Catalog Number: CR3425C

A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.

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GE OEC Medical Systems, Inc recalls OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 680

GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

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GE OEC Medical Systems, Inc recalls OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is des

GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

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Elekta, Inc. recalls Monaco RTP System. Used to make treatment plans for patie

Incorrect dose after editing beam number an wedge angle.

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Meridian Bioscience Inc recalls PREMIER EHEC and PREMIER EHEC Bulk.

Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.

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DICOM GRID INC recalls Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R S

A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.

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Villa Radiology Systems LLC recalls Apollo EZ: Model: 9784152036 Multi-function x-ray systems

The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.

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Acumedia Manufacturers, Inc. recalls Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50K

light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts.

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Villa Radiology Systems LLC recalls Apollo DRF: Model: 9784220831 Multi-function x-ray system

The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.

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Villa Radiology Systems LLC recalls Juno DRF; Model: 709020 Multi-function x-ray systems capa

The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.

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Villa Radiology Systems LLC recalls Apollo: Models: 9784000131, 9784000231, 9784020131, 97840202

The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.

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Zimmer Biomet, Inc. recalls Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femor

labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.

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Vertebral Technologies, Inc. recalls InterFuse Tail Traction Tool, Part Number 9116. The InterFu

Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfuse T tailed implant. The InterFuse T Tail may not fit into the Thru Hole in the instrument.

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Angiodynamics Inc. (Navilyst Medical Inc.) recalls Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distri

The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the device not properly conducting the ECG signal.

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Invacare Corporation recalls Foot Section - BAR5490IVC

A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.

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Merge Healthcare, Inc. recalls Merge PACS software. The firm name on the label is Merge He

Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.

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Invacare Corporation recalls Bariatric Bed - BAR600IVC

The junction box used in the bariatric bed may emit sparks and result in a fire.

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