Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0196-06

Analogic SyneRad Multi Digital Radiology System, Model AN6150

Analogic Corp. / initiated 2005-10-14 / Terminated / root cause: manufacturing process

Analogic Corporation began a recall of Analogic SyneRad Multi Digital Radiology System, Model AN6150 on . The reason FDA records is "Potential weld defect in the Overhead Tube Support assembly which connects to the telescoping arm. This could cause the tube assembly to fall, leading to possiible injury of the user or patient". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0196-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Analogic Corp.
Product
Analogic SyneRad Multi Digital Radiology System, Model AN6150
Product code
KPR System, X-Ray, Stationary
Reason for recall
Potential weld defect in the Overhead Tube Support assembly which connects to the telescoping arm. This could cause the tube assembly to fall, leading to possiible injury of the user or patient.
Root cause tag
manufacturing process
FDA root cause
Other
Action
Analogic Corp notified accounts by email on 10/14/2005 and by letter on 10/17/2005. Accounts are requested to stop use and correction will be conducted by a service engineer.
Quantity in commerce
17 UNITS
Distribution
AZ, CA, FL, MA, OH, PA, TN, TX,
Product codes and lots
Serial Numbers: 3604-M0120;5004-M0125;3204-M0118; 5004-M0126;4404-M0124;3204-M0119;3005-M0131;2404-M0115;2404-M0117;0205-M0130;3604-M0121;3904-M0122;5004-M0127;3805-M0132;2705-M0128;3904-M0123;0205-M0129