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
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