FDA Medical Device Recalls (openFDA)
American Stress Technologies, Inc.: Prism Laser 7642 Laser System
- Recall number
- Z-2600-2011
- Recalling firm
- American Stress Technologies, Inc.
- Product
- Prism Laser 7642 Laser System
- Status
- Terminated
- Initiated
- 2011-04-27
- Posted
- 2011-08-29
- Terminated
- 2016-10-13
- Reason
- It was discovered The Prism 7642 was not certified at the time of delivery. The product lacks the required labeling and the product was sold and delivered without the submission of the Initial Product Report. The product lacks User In formation
- Root cause
- Radiation Control for Health and Safety Act
- Action
- American Stress Technologies sent a customer notification letter dated April 1, 2011, informing them of the action they have taken to correct this issue. (1) ASTI conducted laser safety tests and checks on May 3,2011 to verify the Prism was compliant with FDA regulations. This was confirmed in a June 17, 2011, electronic mail message. (2) ASTI placed the required labels described in the initial product report on the Prism on May 3, 2011. (3) ASTI delivered updated user manuals to UNO on May 3, 2011, that describe potential laser hazards and the required labeling in the same way as described in the initial product report. (4) ASTI completed the above corrective actions at no cost to UNO as confirmed in a June 20, 2011, electronic mail message. If you have any further questions please call (724) 410-1030
- Quantity
- 1
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- S/N 7642/2009
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REO
- Firm FEI
- 3008905686
- Firm city
- Cheswick
- Firm state
- PA
- 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