AGFA

11 recalls •

• Categories: Diagnostic Equipment, Other Medical Devices, Surgical Instruments

AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.

Class I - Dangerous

When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.

Jun 6, 2014 Diagnostic Equipment Nationwide View Details →

IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

Class I - Dangerous

Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.

Apr 30, 2014 Diagnostic Equipment View Details →

IMPAX RIS QDOC 5.8

Class I - Dangerous

Patient name displayed (printed) on the Patient Report was the wrong patient name.

Jan 8, 2014 Other Medical Devices View Details →

IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).

Class I - Dangerous

System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.

Sep 19, 2013 Diagnostic Equipment Nationwide View Details →

AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.

Class I - Dangerous

Customers could potentially experience intermittent, unintended and illogical movement when using the product.

May 15, 2013 Diagnostic Equipment Nationwide View Details →

IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

Class I - Dangerous

Software design error in IMPAX CV 7.8 SU3

Mar 15, 2013 Surgical Instruments View Details →

IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.

Class I - Dangerous

Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.

Mar 15, 2013 Surgical Instruments Nationwide View Details →

CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.

Class I - Dangerous

The cassettes were shipped with the wrong IP (image plate) size bar code.

Feb 7, 2013 Other Medical Devices Nationwide View Details →

AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device

Class I - Dangerous

Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS).

Aug 9, 2012 Other Medical Devices Nationwide View Details →

IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

Class I - Dangerous

Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.

Jul 27, 2012 Other Medical Devices Nationwide View Details →

IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.

Class I - Dangerous

When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report.

Jul 10, 2012 Surgical Instruments Nationwide View Details →