FDA Medical Device Recalls (openFDA)
COLLINS AEROSPACE: TASE 500 Imaging systems
- Recall number
- Z-1784-2019
- Recalling firm
- COLLINS AEROSPACE
- Product
- TASE 500 Imaging systems
- Status
- Open, Classified
- Initiated
- 2019-01-29
- Posted
- not on file
- Terminated
- not on file
- Reason
- the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Collins Aerospace sent a customer notification letter to affected customers,. The letter identified the affected product problem and actions to be taken. For questions contact Customer Support Team at Support.TASE@collins.com
- Quantity
- 433 in total
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- TASE 500
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RET
- Firm FEI
- 3021214229
- Firm city
- Westford
- 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