AGFA Corp. Recalls
Showing 41-54 of 54 recalls
Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares are used to provide digital X-ray images for pre-surgical orthopedic planning. AGFA Corp., Greenville, South Carolina 29601
Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.
On 2/15/07, AGFA notified their consignees of the situation by sending them "Urgent Medical Device Correction" letters, instructing them on how to work around the problem until the firm was able to install the upgraded software that corrected the problem. On 12/11/2007, the firm reported that the upgraded software had been installed at all affected sites.
Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891
Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.
On 7/27/2007 to 8/16/2007, AGFA Healthcare notified, via telephone, consignees of the situation. On 7/27/2007, a formal customer notification letter was sent to affected consignees, providing them with a respective listing of patients that were potentially affected. AGFA informed the consignees that the firm would correct any incorrect patient ECG data. AGFA also informed their consignees that they would provide a configuration update to correct the problem. A notification confirmation form to be return to the firm was also attached to the notification letter, which also provided the firm's customer service number: (877) 777-2432.
Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".
Consignees were notified by an Urgent Safety Notice letter on/about 05/16/2008. The letter provides the procedure the customer can follow to change the film calibration setting from "OFF" to "ON". The letter also provides information on how to get assistance from Agfa, if the customers prefer a service engineer perform the change. Consignees were instructed to send a copy of the letter or similar letter to their affected accounts. Agfa also offers to dispatch a service engineer to perform the parameter change.
Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System.
MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.
On 6/21-26/2007, AGFA Healthcare notified, via telephone, the affected consignees of the situation. On 7/2/2007, affected consignees were sent, via registered mail, an "Urgent Medical Device Correction" letter instructing them to: a) remove the affected software DICOMstore 2.04.40.00 and replace it with the prior software version, DICOMstore 2.04.34.02; and b) review patient ECG reports to determine if any patients were actually affected and to notify the firm. AGFA Healthcare also provided a customer service contact number (877) 777-2432.
CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).
Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.
A Service Bulletin to address the issues was created on 09/01/2006. Customers were notified of the plans to upgrade via telephone and email on 10/13/2006.
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
Consignees were notified by letter on/about 06/28/2006.
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
Failed CAD displayed as 'No Findings'
Consignees were notified by letter on/about 08/08/2006.
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images.
Possible corrupted image appearing after System Start.
On 06/30/2006 Agfa upgraded the Software on the installed units using a Mandatory Service Bulletin DD+DIS225.06E.
Mamoray HDR-C PLUS Mammography film
The film was incorrectly notched.
Consignees were notified by letter on/about 02/16/2006.
Cronex 10T, 14x17, Medical Screen Film, X-ray Film, 100 Sheet Box
A localized fog pattern appears on the film.
Consignees were notified by telephone on 02/16/2006.
CR DX-S, DX-S, Computed radiography system (Digitizer)
Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.
Consignees were notified at the time of upgrading. The software was upgraded on 11/3/2005, 12/19/2005 and 12/28/2005. A Mandatory Service Bulletin, No. 11, explaining the issues was shared with the accounts.
Radiomat Lightweight Cassettes
Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.
Consignees were notified by letter on/about 07/29/2005.
Agfa Cronex 10T Radiographic film
Mislabeling; Product labeled Cronex 10T actually contains Afga, Curix Ultra UVL Plus.
Consignees were first contact by telephone followed up with a certified letter, on/about 12/21/2005.
SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.
The GS1 circuit board may fail resulting in smoke or fire.
Consignees were notified by letter on 11/25/2003. They were informed of the problem and were advised, if they have the affected type and serial number, to contact the Agfa service representative to arrange for repair. The firm intends to install a modified circuit board on each machine remaining in operation at customer locations. Consignees were instructed to discontinue use of the device immediately and to disconnect the unit from the power supply if any odor of smoke or fire is detected. They were urged to complete the Customer Acknowledgement form included with the letter and return it in the enclosed postage paid envelope.