Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C
FDA Recall Z-0099-04 · Posted 2004-07-20
Recall StatusTerminated
Product CodeEHD
Date Initiated2003-10-10
Date Terminated2005-01-13
Product Quantity536 units
Reason for Recall
The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories.
Firm Action
The firm sent a letter dated, October 10, 2003 indicating the firm''s service representatives will upgrade the cable carrier by mounting a safety catch inside the cable carrier.
Root Cause
Other
Distribution Pattern
The firm distributes to hospitals and medical centers nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.