Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to prod
FDA device recall Z-0979-2015 · posted 2015-01-15 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
- Action taken
- Philips sent an Urgent - Field Safety Notice letter dated December 4, 2014 to all affected customers. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, A Field Service Engineer will service the system to resolve the issue. For questions contact your local Philips representative or local Philips Healthcare office.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 500 units
- Distribution
- US Nationwide Distribution - AR, AZ, CA, CO, FL, FL, GA, IL, IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, OR, PA, PA, SC, TN, TX, VA, and WA. The affected product was also distributed to one government con
- Date initiated
- 2014-12-08
- Date posted
- 2015-01-15
- Date terminated
- 2015-10-01
- 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 |
|---|---|---|
| BRILLIANCE VOLUME (K060937) | Philips Medical Systems (Cleveland), Inc. | 2006-06-05 |
| ACQSIM-MULTISLICE-CT, MODEL 453567042271 (K033357) | Philips Medical Systems (Cleveland), Inc. | 2004-01-09 |
| PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326) | Philips Medical Systems, Inc. | 2003-10-29 |
| MX8000 IDT CT SYSTEM (K012009) | Marconi Medical Systems, Inc. | 2001-09-13 |