FDA Medical Device Recalls (openFDA)
Shimadzu Medical Systems Usa Com: BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.
- Recall number
- Z-0959-2019
- Recalling firm
- Shimadzu Medical Systems Usa Com
- Product
- BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.
- Status
- Terminated
- Initiated
- 2019-01-14
- Posted
- not on file
- Terminated
- 2024-06-07
- Reason
- Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure.
- Root cause
- Software design
- Action
- Shimadzu sent an Urgent Medical Device Correction Notice letter dated January 2, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. The letters to the end users explain the problem and a workaround. A service representative will contact the end user to schedule a software update.
- Quantity
- 8 units
- Distribution
- US Nationwide Distribution in the states of IN, OH, IL, SC
- Lot, serial or model codes
- Serial Numbers: 40AD58C4B001, 40AD58C55001, 0261Q80503, 0261Q80804, 0161Q84501, 0161Q83102, 3M7A16A1A001, 0161Q82302
- 510(k) numbers
- ["K062360"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 1000125362
- Firm city
- Torrance
- Firm state
- CA
- 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