Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography images on tr
FDA device recall Z-2136-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LMC
- Quantity affected
- 33 units
- Distribution
- Worldwide Distribution --- USA including states of DE, FL, IL, KS, MA, MD, ME, MO, MT, NJ, NY, OH, OK, TX, UT, VA, WA, WV, and Puerto Rico and country of Canada.
- Date initiated
- 2008-05-16
- Date posted
- 2008-09-18
- Date terminated
- 2008-10-10
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRYSTAR AXYS, MODEL EYZ4E (K072680) | Agfa Healthcare Corporation | 2007-10-25 |