BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designed for single or dual detector
FDA device recall Z-1752-2017 · posted 2017-04-06 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
- Action taken
- Philips Healthcare sent an Urgent Field Safety Notice letter informing consignees of the issue through: Field Safety Notice (FSN) CLE17-006_88200502_88200503. Customers will be notified by direct communication from Philips Field Service Engineers (FSE). A copy of the FSN will be provided to customers by the FSE during the onsite visit for the inspection. A Business Reply form is attached to the FSN for customers to acknowledge receipt and understanding of the FSN. Customers with questions were instructed to contact the Customer Care Solutions Center at 1-800-722-9377. For questions regarding this recall call 440-483-7600.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 0
- Distribution
- Worldwide distribution - US including AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, WI, and WV. Internationally to Australia, Austria, Bel
- Date initiated
- 2017-02-24
- Date posted
- 2017-04-06
- Date terminated
- 2018-07-02
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRIGHTVIEW VCT IMAGING SYSTEM (K080927) | Philips Medical Systems (Cleveland), Inc. | 2008-04-11 |
| APOLLO GAMMA CAMERA SYSTEM (K062298) | Adac Laboratories | 2006-08-23 |