Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance series CT s
FDA device recall Z-0597-2009 · posted 2009-01-16 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- The product is being recalled because the patient support may travel downwards without being commanded to move.
- Action taken
- A On 11/15/2007 & 6/6/2008 the firm sent Urgent Device Notification letters to their customers. They notified their customers that a Field Service Engineer will inspect and repair the brake system.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 559
- Distribution
- Worldwide Distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX,
- Date initiated
- 2008-09-23
- Date posted
- 2009-01-16
- Date terminated
- 2012-03-01
- 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 |
|---|---|---|
| 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 |
| MX8000 V5.0 CT SYSTEM (K010817) | Philips Medical Systems (Cleveland), Inc. | 2001-06-15 |