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
This recall has been terminated (originally issued September 28, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- September 12, 2012
- Posted
- September 28, 2012
- Terminated
- July 26, 2013
- Recall Number
- Z-2494-2012
- Quantity
- 536 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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
Distribution
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.
Lot / Code Info
Serial number range (patient carriage) from: 00 000 00 to 09 000 543.
Root Cause
Device Design
Action Taken
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.