Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the predicate devi
FDA device recall Z-0591-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 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.
- Date initiated
- 2011-12-06
- Date posted
- 2012-01-11
- Date terminated
- 2012-04-11
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS (K092238) | Agfa Healthcare N.V. | 2009-08-11 |