GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fix
FDA device recall Z-2037-2014 · posted 2014-07-10 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. If this occurs it results in an inability to close E-Stop and the system is not operational for clinical use. This problem occurs randomly.
- Action taken
- Philips Healthcare is informing the consignee of this issue through a Field Safety Notice (FSN) 88200487-488. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to install the software update.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 33
- Distribution
- Distributed in the states of CA, CO, IL, OK, OR and WI.
- Date initiated
- 2014-06-18
- Date posted
- 2014-07-10
- Date terminated
- 2015-09-16
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMINI CONDOR (K081135) | Philips Medical Systems (Cleveland), Inc. | 2008-04-29 |
| GEMINI RAPTOR (K052640) | Philips Medical Systems (Cleveland), Inc. | 2005-10-07 |