FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
- Recall number
- Z-1821-2012
- Recalling firm
- Philips Healthcare Inc.
- Product
- Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
- Status
- Terminated
- Initiated
- 2012-05-11
- Posted
- 2012-06-18
- Terminated
- 2016-10-06
- Reason
- If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be execut
- Root cause
- Device Design
- Action
- Philips sent an Urgent - Field Safety Notice letter dated May 11, 2012 to their affected customers. The letter identified the affected product, what the issues are, under what circumstances they may occur and the actions to be taken to avoid or minimize the occurrence of the issue Philips plans to supply an Addendum to the Instruction for Use. A Philips Service Engineer will contact the affected customers as soon as the Field Action Kit is ready to be implemented. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377.
- Quantity
- 6
- Distribution
- 6 US customers
- Lot, serial or model codes
- All systems with Eleva software version 4.x and stitching option.
- 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