Z-0358-04

Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp

Name: Z-0358-04 Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp
Creator: Draeger Medical, Inc.
Published: 2004-01-09
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2004-01-09 / Terminated

FDA source

Draeger Medical, Inc. began a recall of Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp on 2004-01-09. The reason FDA records is "adjustment screw may break due to material fatigue". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0358-04
Status: Terminated
Initiated: 2004-01-09
Posted: 2004-01-22
Terminated: 2004-08-19
Recalling firm: Draeger, Inc.
Product: Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp
Product code: FTD Lamp, Surgical
Reason for recall: adjustment screw may break due to material fatigue
FDA root cause: Other
Action: The recalling firm issued a recall letter dated 1/9/03 to their direct accounts. The recall letter informed the accounts of the problem, the potential danger, and that they will be contacted to schedule replacement.
Quantity in commerce: 51 units
Distribution: Nationwide and Canada. The products were shipped to medical facilities in CA, CO, FL, GA, IL, IN, KS, MO, NC, NV, OH, TX, and VA. The product was also shipped to a medical facility in Canada.
Product codes and lots: Catalog numbers 4115571, YG18568, YG19051, and YG19262

Product code FTD

K010724Class IISola 700,Sola 500, Sola 300Drager Medizintechnik GmbH / cleared 2001-06-07

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)