Tomoscan
FDA device recall Z-0682-05 · posted 2005-04-06 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- Potential for shift of reference lines.
- Action taken
- On 2/10/05 the firm''s field engineers began visiting customer sites providing them with an addendum to the Instructions for Use Manual.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 138
- Distribution
- Devcices were distributed to hospitals and medical centers throughout the U.S.
- Date initiated
- 2005-02-10
- Date posted
- 2005-04-06
- Date terminated
- 2008-05-09
- Location
- Bothell, WA
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