FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
- Recall number
- Z-1538-2012
- Recalling firm
- Philips Healthcare Inc.
- Product
- Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
- Status
- Terminated
- Initiated
- 2011-10-19
- Posted
- 2012-06-13
- Terminated
- 2017-01-18
- Reason
- When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when component supplie
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips Healthcare sent a proprosed corrective action letter dated May 3, 2012, to FDA. The proposed corrective action plan is to bring the product into compliance with regulatory requirements by issuing a field corrective action which should be completed by Philips by August 1, 2012. For questions regarding this recall call 978-687-1501.
- Quantity
- 11 - US
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- n/a
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IZL
- 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