ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line.
This recall has been terminated (originally issued January 6, 2006).
- Company
- Agfa Corp.
- Recall Initiated
- November 18, 2005
- Posted
- January 6, 2006
- Terminated
- January 12, 2012
- Recall Number
- Z-0352-06
- Quantity
- 1059 units
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.
Distribution
Nationwide
Lot / Code Info
Serial Numbers: ADC Solo: Units with Serial numbers les than 4748, Initia CR1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP100: all serial numbers are considered affected unless they have been upgraded to software version SOL_2205 or later.
Root Cause
Other
Action Taken
Consignees were notified by letter on/about December 1, 2005.
More recalls by Agfa Corp.
AGFA Digital Radiography X-Ray system DX-D 100
Agfa's DX-D 100 is indicated for use in providing di...
Jul 21, 2014
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognitio...
May 27, 2014
IMPAX RIS QDOC 5.8
Feb 3, 2014