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Terminated

Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive

FDA Recall Z-0009-04 · Posted 2003-10-15

Recall StatusTerminated
Product CodeJAA
Date Initiated2003-08-08
Date Terminated2004-01-16
Product Quantity34 units

Reason for Recall

possible movement of table tilt and table longitudinal

Firm Action

The recalling firm issued Update Instructions SP016/03/S, SP017/03S and SP018/03/S that instruct the Service Engineers to visit each affected system to install the required parts.

Root Cause

Other

Distribution Pattern

Nationwide. The product was shipped to medical facilities in CA, FL, GA, IL, MD, NC, NJ, NY, OK, PA, SC, TN, TX, VA, WI, and WV.

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.

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