FDA Medical Device Recalls (openFDA)
Philips Medical Systems Gmbh, DMC: Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System.
- Recall number
- Z-1283-2012
- Recalling firm
- Philips Medical Systems Gmbh, DMC
- Product
- Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System.
- Status
- Terminated
- Initiated
- 2012-03-09
- Posted
- 2012-03-23
- Terminated
- 2013-05-23
- Reason
- Underexposed image due to lag in switching between auxiliaries
- Root cause
- Software design
- Action
- Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated February 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm provided a work around for customers to use until a software update can be installed. Customers should contact their local Philips representative for questions regarding this notice.
- Quantity
- 88 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Germany, Indonesia, Malaysia, Saudi-Arabia, Singapore, and Thailand.
- Lot, serial or model codes
- Software release 4.0
- 510(k) numbers
- ["K031535"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 3003768251
- Firm city
- Hamburg
- Firm state
- not on file
- Firm country
- Germany
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