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Terminated

Drager Surgical Lights Sola 500 and Sola 700.

FDA Recall Z-2212-2009 · Posted 2009-09-16

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeFTD
Date Initiated2009-08-26
Date Terminated2010-03-08
Product Quantity20 units

Reason for Recall

welded seam may fail

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution -- IL, KY, and PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010724SOLA 700,SOLA 500, SOLA 300Drager Medizintechnik GmbH · 2001-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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