Recall Z-0700-2013— AMS Innovative Center - San Jose
Class II · Terminated
Class II FDA medical device recall by AMS Innovative Center - San Jose, initiated 2012-12-11, terminated 2014-02-13. It names 2 FDA 510(k) clearances: K092735, K062719. Product: GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia.. Reason: During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard..
- Recalling firm
- AMS Innovative Center - San Jose
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-11
- Terminated
- 2014-02-13
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K092735 — GREENLIGHT XPS LASER SYSTEM
- K062719 — GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia.
Reason for recall
During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
Data sourced from openFDA. This site is unofficial and independent of the FDA.