FDA Device recall Z-1774-2013
PASCAL and PASCAL Streamline (532 nm.577 nm)
- FDA Device
- Class II
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class II recall of PASCAL and PASCAL Streamline (532 nm.577 nm) by Topcon Medical Laser Systems, citing when using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under tre….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1774-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-03-27 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Topcon Medical Laser Systems |
| Distribution | n/a |
Product
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Reason
When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.
Identifiers
| code_info | PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x Serial numbers: United States 33057910…PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x Serial numbers: United States 33057910 33060410 33063610 66078611 66084911 66085111 66085511 Out of United States OMC-179 11138509 11141209 11147209 11147809 11148910 11149010 11149210 11149710 . 11149810 11150110 11150210 11150410 11150610 11150810 11150910 11151010 1 151110 11151211 33054310 33059310 33059510 33062810" 66075211' 66076711 66077111 66078011 66079911 6608391'1 66084611 66084811 66085011 66085211 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1774-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.