FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
- Recall number
- Z-2384-2012
- Recalling firm
- Philips Healthcare Inc.
- Product
- Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
- Status
- Terminated
- Initiated
- 2012-08-14
- Posted
- 2012-09-14
- Terminated
- 2017-01-17
- Reason
- Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.
- Root cause
- Device Design
- Action
- Philips Healthcare Imaging issued an Urgent - Field Safety Notice dated August 8, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The unit will be exchanged with a new unit that complies with the IEC requirements. Please reference Field Change Order (FCO) 71200081 when contacting I your local Philips representative. 1-800-722-9377. Customer were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter and to maintain a copy of the letter with the equipment instruction for Use. For further assistance, customers should contact their local Phillips representative: Technical Support Line 1-800-722-9377. For questions regarding this recall call 978-687-1501.
- Quantity
- 4 systems
- Distribution
- Worldwide Distribution - USA including OH and WA and the country of Canada
- Lot, serial or model codes
- Lot or Serial Numbers With affected M-cabinet CXA; Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003
- 510(k) numbers
- ["K982795"]
- PMA numbers
- not on file
- Product code
- MQB
- 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