Home / Recalls / AGFA Corp. / Z-2081-2014

Z-2081-2014 Class II Terminated

Recalled by AGFA Corp. — Greenville, SC

FDA device recall Z-2081-2014 was initiated by AGFA Corp. on June 6, 2014 and is designated Class II. Reason for recall: When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings. The recall status is terminated (terminated June 27, 2016). Affected quantity: 216 units.

Recall Details

Product Type
Devices
Report Date
July 30, 2014
Initiation Date
June 6, 2014
Termination Date
June 27, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
216 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

USA (nationwide) including the states of AL, CA, FL, GA, IL, IN, IA, KY, LA, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, SC, TN, TX, VA, WV, WI, WY and Internationally to Canada.

Code Information

Serial # A5410000053, A5410000054, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5411000315, A5411000331, A5411000332, A5411000141, A5411000144, A5411000038, A5411000069, A5411000133, A5411000175, A5411000119, A5411000123, A5411000333, A5411000334, A5410000038, A5411000019, A5411000047, A5411000048, A5411000053, A5410000041, A5410000042, A5410000046, A5410000016, A5410000039, A5410000021, A5410000023, A5411000074, A5411000080, A5411000024, A5411000184, A5411000193, A5411000196, A5410000100, A5410000114, A5410000115, A5410000116, A5410000117, A5411000342, A5411000343, A5411000344, A5411000366, A5411000368, A5411000237, A5411000027, A5411000020, A5411000021, A5411000132, A5411000070, A5411000078, A5411000082, A5411000154, A5411000156, A54110000107, A5410000082, A5410000066, A5411000236, A5411000155, A5411000151, A5411000148, A5411000149, A5411000134, A5411000120, A5411000125, A5411000147, A5410000079, A5411000185, A5411000191, A5411000192, A5411000194, A5411000239, A5411000052, A5411000030, A5411000314, A5411000348, A5411000268, A5411000347, A5411000349, A5411000140, A5411000142, A5411000097, A5410000022, A5411000017, A5410000027, A5411000153, A5411000233, A5411000234, A5411000235, A5411000318, A5410000044, A5411000037, A5410000043, A5411000181, A5411000158, A5411000152, A5411000263, A5411000309, A5411000199, A5411000209, A5411000210, A5411000232, A5411000346, A5411000124, A5411000174, A5411000177, A5411000230, A5411000173, A5411000316, A5411000145, A5411000188, A5411000197, A5411000202, A5411000203, A5411000206, A5411000208, A5411000335, A5411000336, A5411000159, A5411000041, A5411000050, A5411000088, A5411000247, A5411000079, A5411000040, A5411000240, A5411000085, A5411000277, A5411000278, A5411000279, A5411000280, A5411000281, A5411000282, A5411000245, A5411000064, A5411000065, A5411000187, A5411000198, A5411000207, A5411000211, A5411000212, A5411000231, A5411000039, A5411000032, A5411000083, A5411000122, A5411000108, A5411000110, A5411000241, A5411000246, A5411000114, A5411000033, A5411000139, A5411000312, A5411000182, A5411000190, A5411000218, A5411000249, A5411000084, A5411000098, A5411000238, A5411000116, A5410000042, A5411000023, A5411000337, A5411000338, A5411000340, A5411000314, A5411000117, A5411000121, A5411000262, A5411000270, A5411000272, A5411000273, A5411000293, A5411000260, A5411000264, A5411000269, A5411000271, A5411000291, A5411000292, A5411000261, A5411000265, A5411000266, A5411000267, A5411000363, A5411000034, A5411000025, A5411000081, A5411000146, A5411000092, A5411000093, A5411000026, A5411000068, A5411000131, A5411000060, A5411000018, A5411000100, A5411000313, A5411000284, A5411000076, A5411000135, A5411000180, A5411000285, A5411000311, A5411000286, A5411000062, A5411000136, A5411000178, A5411000179, A5411000283

Other recalls by AGFA Corp.

  • Z-1662-2014 Class II — IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical (April 30, 2014)
  • Z-0919-2014 Class II — IMPAX RIS QDOC 5.8 (January 8, 2014)
  • Z-0035-2014 Class II — IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archivi (September 19, 2013)
  • Z-1487-2013 Class II — AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated f (May 15, 2013)
  • Z-1070-2013 Class II — IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reportin (March 15, 2013)
  • Z-1069-2013 Class II — IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates (March 15, 2013)
  • Z-0970-2013 Class II — CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM (February 7, 2013)
  • Z-2252-2012 Class II — AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore (August 9, 2012)
  • Z-2184-2012 Class II — IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured report (July 27, 2012)
  • Z-2069-2012 Class II — IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component f (July 10, 2012)

FDA data resources