FDA Medical Device Recalls (openFDA)
Sedecal USA, Inc.: Sedecal SA Mobile Diagnost w DR x-ray system
- Recall number
- Z-1691-2016
- Recalling firm
- Sedecal USA, Inc.
- Product
- Sedecal SA Mobile Diagnost w DR x-ray system
- Status
- Terminated
- Initiated
- 2015-03-23
- Posted
- not on file
- Terminated
- 2018-03-09
- Reason
- Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type " Newborn" was selected and is displayed in the generator control area of the Eleva User Interface.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Sedecal USA has developed a new software release to address this issue. The distributor of this product, Philip, will modify the systems in the field to correct the defect at no cost to the customer. 1. You will contact customers and initiate a software update to correct the two defects. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (847) 394-6960.
- Quantity
- US - 145
- Distribution
- US Distribution - TX, OH, NY, MD, IN, PA, DE, WA, NH, AZ, GA, NC, UT, VT, CA, LA, NJ, MN, FL, WI, HI, IA, MA, ME, TN, CT, ID, MI, AR and KS.
- Lot, serial or model codes
- System Code 712001
- 510(k) numbers
- ["K111725"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 1000139935
- Firm city
- Buffalo Grove
- Firm state
- IL
- 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