Philips Healthcare IQon Spectral CT computed tomography x-ray system
This recall has been terminated (originally issued November 8, 2017).
- Recall Initiated
- November 8, 2017
- Terminated
- April 17, 2020
- Recall Number
- Z-0333-2018
- Quantity
- 50
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Distribution
107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
Lot / Code Info
IQon Spectral CT 728332 Devices manufactured 03/05/2009 to present.
Root Cause
Device Design
Action Taken
Philips Healthcare is informing consignees of this issue through a Customer Information Letter (CIL_FCO72800690). Philips Key Market representatives will distribute the letter internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Customers are notified that if they hear an unusual noise coming from the gantry, or scan halts, the Philips representative should be contacted as soon as possible. Philips will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost.