Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisitio
FDA device recall Z-0513-2018 · posted 2018-02-03 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
- Action taken
- Philips sent an Urgent Field Safety Notice letter dated December 15, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Philips representative.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 1387 in total
- Distribution
- Worldwide Distribution - US Nationwide
- Date initiated
- 2017-12-15
- Date posted
- 2018-02-03
- Date terminated
- 2020-04-10
- Location
- Cleveland, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRIFFIN SPECT/CT IMAGING SYSTEM (K041218) | Adac Laboratories | 2004-05-24 |