Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000
FDA device recall Z-0494-2010 · posted 2010-01-21 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- Failure to provide the complete User Manual information.
- Action taken
- A Field Modification Instruction will be released in February 2010. GE Healthcare will correct the Operator Manuals in forward production and the installed base units.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 343 total
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-08-01
- Date posted
- 2010-01-21
- Date terminated
- 2012-02-04
- Location
- Waukesha, WI
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