Device product
Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System
Z-2494-2012
Product summary
- Event
- Event 63165
- Status
- Terminated
- Classification
- Class II
- Quantity
- 536 units
- Official record key
device-enforcement:Z-2494-2012
Official wording
Reason: Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator
Code information: Serial number range (patient carriage) from: 00 000 00 to 09 000 543.
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of :Australia, Austria, Bahrain, Belgium, Canada, Chile, China, Czech Republic, Denmark, Finland, , France, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Russia, Saudi Arabia, Sweden, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan. Thailand, Turkey,United Arab Emirates and United Kingdom.
Derived failure modes
-
Unknown
Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator