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Terminated

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

FDA Recall Z-0358-04 · Posted 2004-01-22

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeFTD
Date Initiated2004-01-09
Date Terminated2004-08-19
Product Quantity51 units

Reason for Recall

adjustment screw may break due to material fatigue

Firm 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.

Root Cause

Other

Distribution Pattern

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.

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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