FDA Medical Device Recalls (openFDA)
Fischer Imaging Corporation: VersaRad Generator
- Recall number
- Z-0787-05
- Recalling firm
- Fischer Imaging Corporation
- Product
- VersaRad Generator
- Status
- Terminated
- Initiated
- 2004-09-30
- Posted
- 2005-05-03
- Terminated
- 2012-03-13
- Reason
- Some VersaRad Systems have a faulty weld that may result in oil leakage.
- Root cause
- Other
- Action
- Customers were sent notification letters.
- Quantity
- 38 units
- Distribution
- Domestic distribution: ... International distribution: Germany, Greece, Italy, Kuwait, Spain, Sweden, Switzerland. No VA or military facilities.
- Lot, serial or model codes
- Generator S/N''s: 9918-0704-002; 9918-0804-003; 9918-0804-007; 9918-0804-005; 9918-0204-001; 9918-0304-001; 9918-0304-003; 9918-03304-004; 9918-0505-002; 9918-0604-001; 9918-0604-003; 9918-0604-006; 9918-0704-001; 9918-0704-003; 9918-0704-004; 9918-0704-005; 9918-0803-002; 9918-0804-002; 9918-0903-002; 9918-1003-001; 9918-1203-002; 9918-0604-007; 9918-0804-004; 9918-0404-002; 9918-0803-001; 9918-0504-003; 0304-002; 0404-003; 0504-004; 9918-0604-005; 9918-0903-001; 9918-0404-001; 9918-0604-002; 9918-0504-001; 9918-0804-001; 9918-1103-001; 9918-1203-001; 9918-0604-004.
- 510(k) numbers
- ["K880530"]
- PMA numbers
- not on file
- Product code
- IYB
- Firm FEI
- 1418957
- Firm city
- Denver
- Firm state
- CO
- 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