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Recall Observatory FDA recall evidence

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

September 12, 2012

Class II

Product summary

Firm
Philips Healthcare Inc.
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

    reason.no_named_rule · v1.0.0

    Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator