The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.

Class IIModerate

FDAAug 13, 2014Nationwide• Siemens Healthcare Diagnostics

Metoclopramide Oral Solution (VistaPharm) – Defective Container Leak (2014)

Defective Container: Product leaks when inverted.

Class IIModerate

FDAAug 13, 2014Nationwide• VistaPharm, Inc.

TrakBack II Pullback Device (Volcano) – Sterile Barrier Breach (2014)

Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.

Class IIModerate

FDAAug 13, 2014Nationwide• Volcano Corporation

The Siemens Symbia S series is intended for use by approp... (Siemens Medical Solutions USA, Inc.) – siemens medical solutions usa, inc (2014)

Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.

Class IIModerate

FDAAug 12, 2014Nationwide• Siemens Medical Solutions USA, Inc.

PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin... (Ethicon Endo-Surgery Inc) – fire hazard (2014)

Fire/Burn Risk

The device may have a non-conforming component that may cause the device to fire an unformed staple.

Class IIModerate

FDAAug 12, 2014Nationwide• Ethicon Endo-Surgery Inc

The Siemens Symbia T series is intended for use by approp... (Siemens Medical Solutions USA, Inc.) – siemens medical solutions usa, inc (2014)

Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.

Class IIModerate

FDAAug 12, 2014Nationwide• Siemens Medical Solutions USA, Inc.

eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch ... (Gendex Corp) – two (2) failures of the spring link c... (2014)

Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.

Class IIModerate

FDAAug 12, 2014Nationwide• Gendex Corp

AXIOM Luminos dRF system with SW VD10 or on Luminos dRF M... (Siemens Medical Solutions USA, Inc) – it was determined that a potential ma... (2014)

It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tableside control panel and result in malfunction. In the very unlikely case of fluid infiltration a permanent short circuit within the control panel of the Luminos dRF / Luminos dRF Max will automatically d

Class IIModerate

FDAAug 12, 2014Nationwide• Siemens Medical Solutions USA, Inc

The Symbia Intevo Excel is a non-diagnostic SPECT ICT sys... (Siemens Medical Solutions USA, Inc.) – siemens medical solutions usa, inc (2014)

Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.

Class IIModerate

FDAAug 12, 2014Nationwide• Siemens Medical Solutions USA, Inc.

Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend P... (Primus Medical LLC) – the firm found that the top cover of ... (2014)

The firm found that the top cover of the mattresses were delaminating.

Class IIModerate

FDAAug 11, 2014AZ, CA, CO +16 more• Primus Medical LLC

Purple Corn Drink (JP Trading) – Undeclared Colors (2014)

Undeclared Allergen

Tradiciones' Andinas Purple Corn Drink Chicha Morada contains undeclared FD & C Blue #1, Yellow #5 and contains unallowable dye: 16185- Amaranth (E123) - delisted FD & C Red 2.

Class IIModerate

FDAAug 11, 2014CT, NJ, NY• JP Trading and Global Imports LLC

ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 P... (Horiba Instruments, Inc dba Horiba Medical) – horiba medical is recalling the abx p... (2014)

Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stability claim.

Class IIModerate

FDAAug 11, 2014Nationwide• Horiba Instruments, Inc dba Horiba Medical

Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endoss... (Instradent USA, Inc.) – product not approved for use in the us (2014)

Product not approved for use in the US

Class IIModerate

FDAAug 11, 2014Nationwide• Instradent USA, Inc.

CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-s... (GE Healthcare, LLC) – ge healthcare has recently become awa... (2014)

GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units.

Class IIModerate

FDAAug 8, 2014CA, CO, FL +15 more• GE Healthcare, LLC

MicroScan Microbiology Systems: Dried Gram Negative MIC/C... (Beckman Coulter, Inc.) – technical support bulletin issued in ... (2014)

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

Class IIModerate

FDAAug 8, 2014Nationwide• Beckman Coulter, Inc.

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