Recalls / —
—#27933
Product
EasyWeb
- FDA product code
- LLZ — System, Image Processing, Radiological
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K982769
- Affected lot / code info
- The firm assigns a ''site number'' to each device: Z1776, 86233, 86264, 83198, 86944, 85075, 85077, 85083, 85071, 85067, 10377, 85048, 86026, X1676, 83675, 86025, 87131, 87158, 82683, 84027, 84087, 84359, 86007, 84405, 85453, 83917, 85189, 83961
Why it was recalled
Potential for incorrect body part information
Root cause (FDA determination)
Other
Action the firm took
A letter dated 2/13/02 was issued to customers advising that a representative from the firm will install new software.
Recalling firm
- Firm
- Philips Medical Systems
- Address
- 22100 Bothell Everett Highway, Bothell, Washington 98041
Distribution
- Distribution pattern
- The firm distributed units to hospitals and medical centers located throughout the US.
Timeline
- Recall initiated
- 2002-02-13
- Posted by FDA
- 2003-08-12
- Terminated
- 2005-01-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #27933. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.