FDA Medical Device Recalls (openFDA)
AGFA Corp.: Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standand needle phosphor image plates and can be used with either Musica or Musica 2. In the US, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography.
- Recall number
- Z-0591-2012
- Recalling firm
- AGFA Corp.
- Product
- Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standand needle phosphor image plates and can be used with either Musica or Musica 2. In the US, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography.
- Status
- Terminated
- Initiated
- 2011-12-06
- Posted
- 2012-01-11
- Terminated
- 2012-04-11
- Reason
- Occasionally images can be lost or sent to an incorrect folder or the digitizer may stop either during startup or during a cassette scan cycle.
- Root cause
- Software design
- Action
- Agfa HealthCare sent a 'URGENT SAFETY NOTICE" letter dated December 6, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Agfa Service will contact your facility and schedule a software upgrade if this has not already been performed. Please complete the attached feedback form as soon as possible and fax it to 864-421-1662. If you have any questions about this matter, please contact your local Agfa HealthCare Service at 877-777-2432.
- Quantity
- 125
- Distribution
- Worldwide Distribution-- USA (nationwide) including the states of AZ, CA, CO, FL, GA, HI, IL, IN, KS, LA, ME, MI, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI and WV, and Canada.
- Lot, serial or model codes
- Model No. 5170/100
- 510(k) numbers
- ["K092238"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 3001236302
- Firm city
- Greenville
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28