Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray
FDA device recall Z-1588-2013 · posted 2013-06-25 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bol
- Action taken
- Philips Medical Systems sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated Mar 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 50 units
- Distribution
- Nationwide Distribution-including the states of AR, AZ, DE, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, and WY.
- Date initiated
- 2013-03-21
- Date posted
- 2013-06-25
- Date terminated
- 2013-11-27
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326) | Philips Medical Systems, Inc. | 2003-10-29 |