882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In additio
FDA device recall Z-1480-2017 · posted 2017-03-16 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
- Action taken
- Consignees received a customer information letter via certified mail, 1/31/2017. International consignees were notified by Philips Healthcare Global Market representatives. Field Service Engineers are contacting consignees to conduct appropriate corrections. Non-responders will be contacted multiple times.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 1218 total
- Distribution
- Worldwide distribution. US nationwide, ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CAYMEN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGY
- Date initiated
- 2017-01-31
- Date posted
- 2017-03-16
- Date terminated
- 2018-07-02
- 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 |
|---|---|---|
| BRIGHTVIEW VCT IMAGING SYSTEM (K080927) | Philips Medical Systems (Cleveland), Inc. | 2008-04-11 |
| APOLLO GAMMA CAMERA SYSTEM (K062298) | Adac Laboratories | 2006-08-23 |