FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp
- Recall number
- Z-0359-04
- Recalling firm
- Draeger Medical, Inc.
- Product
- Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp
- Status
- Terminated
- Initiated
- 2004-01-09
- Posted
- 2004-01-22
- Terminated
- 2004-08-19
- Reason
- adjustment screw may break due to material fatigue
- 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
- 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.
- Lot, serial or model codes
- Catalog numbers 4115571, YG18568, YG19051, and YG19262
- 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