Z-2212-2009

Drager Surgical Lights Sola 500 and Sola 700

Name: Z-2212-2009 Drager Surgical Lights Sola 500 and Sola 700
Creator: Draeger Medical, Inc.
Published: 2009-08-26
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2009-08-26 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Drager Surgical Lights Sola 500 and Sola 700 on 2009-08-26. The reason FDA records is "welded seam may fail". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2212-2009
Status: Terminated
Initiated: 2009-08-26
Posted: 2009-09-16
Terminated: 2010-03-08
Recalling firm: Draeger, Inc.
Product: Drager Surgical Lights Sola 500 and Sola 700.
Product code: FTD Lamp, Surgical
Reason for recall: welded seam may fail
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Draeger Medical, Inc. issued a "Medical Device Recall" letter dated August 2009 via certified mail with return receipt. Consignees were informed on the affected product and that a service representative will be in contact shortly to schedule a replacement. For further information, contact Draeger Medical at 1-800-543-5047, press 1 at the prompt and then 2349.
Quantity in commerce: 20 units
Distribution: Nationwide Distribution -- IL, KY, and PA.
Product codes and lots: All product with Catalog Number: 4115571.

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