FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: EasyDiagnost
- Recall number
- Z-1659-2009
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- EasyDiagnost
- Status
- Terminated
- Initiated
- 2009-07-06
- Posted
- 2009-09-24
- Terminated
- 2011-12-16
- Reason
- The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch
- Root cause
- Radiation Control for Health and Safety Act
- Action
- A Customer Notification letter describing the potential grid switch failure and actions planned by Philips to correct the problem will be sent to all users of the affected systems during the week of July 6, 2009.
- Quantity
- 27 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Site Numbers: 6983, 38149, 38268, 38314, 38423, 38434, 38608, 38712, 38743, 38745, 41420, 41463, 50230, 52450, 62868, 76578, 76829, 76958, 76959, 76960, 76967, 76973, 85494, 250679, 557988, 557991, and 558209.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- 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