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
FDA Recall Z-2494-2012 · Posted 2012-09-28
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Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeMQB
Date Initiated2012-09-12
Date Terminated2013-07-26
Product Quantity536 units
Reason for Recall
Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator
Firm Action
Philips Healthcare sent an Urgent Field Safety Notice letter dated August 15, 2012 to all affected customers. The letter identified the affected product, problem and the actions to be taken to avoid or minimize the occurrence of the issue. Customers were advised to follow the instruction for Use and that Philips plans to replace the old hook with one that has a new design. For questions contact your local Philips representative 1-800-722-9377.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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