Z-2502-2010

GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose...

Name: Z-2502-2010 GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose...
Creator: AMS Innovative Center - San Jose
Published: 2010-01-22
License: https://open.fda.gov/license/

American Medical Systems Innovation Center - Silicon Valley / initiated 2010-01-22 / Terminated / root cause: labeling and UDI

FDA source

AMS Innovative Center - San Jose began a recall of GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079 on 2010-01-22. The reason FDA records is "Product may be packed with incorrect external or internal labels and/or missing product insert". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2502-2010
Status: Terminated
Initiated: 2010-01-22
Posted: 2010-09-25
Terminated: 2011-01-25
Recalling firm: American Medical Systems Innovation Center - Silicon Valley
Product: GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Product may be packed with incorrect external or internal labels and/or missing product insert.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Notification issued via letter with instructions and response sheet through certified mail on 01/12/2010.
Quantity in commerce: 11668 units
Distribution: Product was distributed to 148 medical facilities throughout the US. and 6 consignees in Great Britain, Canada and Australia.
Product codes and lots: Manufactured between August 21 and October 31, 2009-- Lot number/Affected units: 932: D, N, U, Z; 933: A, C, F, H, K, L, M, T; 934: B, D, N, U, V, W, Y, Z; 935: A, C, F, H, K, L, M, T; 936: B, D, N, U, V, W, Y, Z; 937: A, C, F, H, K, L, M, T; 938: B, D, N, U, V, W, Y, Z; 939: A, B,L, M, T, V, W, Y; 940: B, D, N, U, V, W, Y, Z.

Product code GEX

K062719Class IIGreenlight Hps Series Surgical Laser System & AccessoriesLaserscope / cleared 2006-12-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)