ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, O
FDA device recall Z-0785-2014 · posted 2014-01-17 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment.
- Action taken
- On October 30, 2013 & December 4, 2013, the firm sent Urgent Medical Device Recall letters to their customers.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IZJ
- Quantity affected
- 255 units
- Distribution
- Worldwide Distribution: US (nationwide) including states of: AL, AR, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TN,
- Date initiated
- 2013-12-04
- Date posted
- 2014-01-17
- Date terminated
- 2015-11-06
- 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 |
|---|---|---|
| CIRRUS GAMMA CAMERA (K913471) | Adac Laboratories | 1991-10-23 |