BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView
FDA device recall Z-1481-2013 · posted 2013-06-05 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.
- Action taken
- Philips Healthcare sent an Urgent Medical Device Correction letter dated April 26, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customer were not required to take any specific action. Customers who need further information or support concerning the affected product, they should contact their local lPhilips representative or local Philips Healthcare office. For North Americ and Canada they should contact the Customer Care Solutions Center (1-800-722-9377, option 5). For questions regarding this recall call 440-483-7600.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 505 units
- Distribution
- Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, W
- Date initiated
- 2013-04-25
- Date posted
- 2013-06-05
- Date terminated
- 2014-02-12
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APOLLO GAMMA CAMERA SYSTEM (K062298) | Adac Laboratories | 2006-08-23 |