FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
- Recall number
- Z-2208-2012
- Recalling firm
- Philips Healthcare Inc.
- Product
- Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
- Status
- Terminated
- Initiated
- 2012-07-11
- Posted
- 2012-08-15
- Terminated
- 2017-01-23
- Reason
- Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors.
- Root cause
- Equipment maintenance
- Action
- Philips issued an Urgent Field Safety Notice dated July 9, 2012, to notify users that the inclination swtich may be mounted incorrectly. A Field Safety Engineer will be dispatched to verify if a switch was installed properly, and in the event it was not installed properly they will re-install it properly. The Field Service Engineer will add a label as described in the spare part replacement manual, which is part of the FCO kit.. Customers were instructed review the information contained in the Field Safety Notice and to retain a copy of the notice with the equipment Instruction for Use. For further questions customers were instructed to call their Phillips representataive Technical Support Line at 1-800-722-9377. For questions regarding this recall call 978-687-1501
- Quantity
- 12 units
- Distribution
- Worldwide Distribution - USA including IN, MA, MI, MO, NC, NY PA, SC, and WI and to the countries of Canada, HongKong, New Zealand.
- Lot, serial or model codes
- Serial Numbers: SN07000141 SN07000109 SN5000162 SN5000421 SN07000667 200148 200115 200081 300114
- 510(k) numbers
- ["K031535","K970640"]
- PMA numbers
- not on file
- Product code
- IXR
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28