MultiDiagnost Eleva Part Numbers: 9896 001 41501 and 9896 001 41502
FDA device recall Z-1307-04 · posted 2004-08-04 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.
- Action taken
- The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 8
- Distribution
- Philips Medical Systems North American Company distributes product to medical facilities nationwide.
- Date initiated
- 2004-06-08
- Date posted
- 2004-08-04
- Date terminated
- 2006-02-09
- Location
- Bothell, WA
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