SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661;
FDA device recall Z-0398-2011 · posted 2010-11-17 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Detector arm assembly may slide to hardware limit, potentially causing impact.
- Action taken
- Firm will notify consignees via Urgent - Medical Device Correction, dated Nov 3, 2010, via FedEx. The letter identified the affected product, described the problem, the hazard involved, how to identify affected products, actions to be taken, and actions planned by Philips. Customers are to contact their Field Safety Engineer immediately to schedule an inspection of their system. If customers suspect that the identified problem has occurred with their device, they should immediately stop using the system until Philips has confirmed it as safe to use. If customers need further information concerning this issue, they are to contact their local Philips representative.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 24 units
- Distribution
- Worldwide Distribution -- USA and the Netherlands.
- Date initiated
- 2010-10-15
- Date posted
- 2010-11-17
- Date terminated
- 2012-03-21
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SKYLIGHT IMAGING SYSTEM (K000908) | Adac Laboratories | 2000-04-05 |