Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 4535-602-79811; Product is manu
FDA device recall Z-2872-2011 · posted 2011-07-22 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the pallet and patient table resulting in broken finger bone.
- Action taken
- Philips Healthcare issued a Customer Information letter (Field Change Order (#88200402)) dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the instruction for use for their system, which states "Monitor the patient and the system vigilantly during any system motions to make sure that ...accessories, equipment, and all ojbects such as hair, jewelry, or neckties-remain clear of any moving camera and imaging table parts. For additional information, customers were istructed to see the BrightView SPECT instructions for Use, section 2.2 - Safety Warnings and Precautions and Safety and Information Labels. Philips Healthcare will notify all affected customers and will install a sticker through an Action for Performance - Proactive Field Change Order (FCO) to resolve the issue. For customers in North America who require further information or support contact Customer Care Solutions Center at 1-800-722-9377, Select Option 5. In all other countries the local Philips Healthcare office should be contacted.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 461
- Distribution
- Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, China, Chile, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt,
- Date initiated
- 2011-06-03
- Date posted
- 2011-07-22
- Date terminated
- 2012-11-06
- Location
- San Jose, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APOLLO GAMMA CAMERA SYSTEM (K062298) | Adac Laboratories | 2006-08-23 |