Iowa Recalls

Shimadzu Medical Systems recalls Shimadzu X-ray TV System, Catalog No. SONIALVISION G4

Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.

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Boston Scientific Corporation recalls Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.

Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.

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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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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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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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Carestream Health Inc recalls Carestream Touch Prime, Catalog # 1738830, and Touch Prime X

Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i.e., centimeters or millimeters. As such, the user expects that the measurement is taken calculated in centimeters, consistent with other values in the report. In actuality, the measurement is taken in millimeters. When this updated measurement is used in an average calculation, the result appears incorrect as two measurements are interpreted as centimeters while the user corrected value is interpreted as millimeters. If the user selects a Calc Result display as Min or Max, the values are also interpreted as millimeters when centimeters were expected.

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The Binding Site Group, Ltd. recalls Digital RID Plate Reader and Software Product Code: AD400

If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.

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Mesa Laboratories Inc recalls ProSpore 4 mL Ampoule Biological indicator for steam sterili

Product resistance has fallen outside of label claim within expiry.

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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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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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INO Therapeutics (dba Ikaria) recalls Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery syste

Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device.

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Teleflex Medical recalls Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and She

Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.

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Tosoh Bioscience, Inc. recalls Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.

The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the diagnostic medical decision point of 6.5%.

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BioMerieux SA recalls ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-4

Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.

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Cook Inc. recalls Flexor Radial Access Set, Individual product is packaged in

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

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