FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: Drager Surgical Lights Sola 500 and Sola 700.
- Recall number
- Z-2212-2009
- Recalling firm
- Draeger Medical, Inc.
- Product
- Drager Surgical Lights Sola 500 and Sola 700.
- Status
- Terminated
- Initiated
- 2009-08-26
- Posted
- 2009-09-16
- Terminated
- 2010-03-08
- Reason
- welded seam may fail
- 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
- 20 units
- Distribution
- Nationwide Distribution -- IL, KY, and PA.
- Lot, serial or model codes
- All product with Catalog Number: 4115571.
- 510(k) numbers
- ["K010724"]
- PMA numbers
- not on file
- Product code
- FTD
- Firm FEI
- 2517967
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28