FDA Device Recall Z-0009-04: Siemens Medical Solutions USA, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0009-04.

Recall Res Number

Z-0009-04

Recalling Firm / Manufacturer

Siemens Medical Solutions USA, Inc

FEI Number

2240869

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2003-08-08

Date Posted

2003-10-15

Date Terminated

2004-01-16

Product Code

JAA

Event Number

27023

Product Quantity

34 units

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

Reason for Recall possible movement of table tilt and table longitudinal

Action Details 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.

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.

Code Information / Serial Numbers Uroskop D1/D2/D3

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FUJIFILM CORPORATION Registration: 3001722928 View Registration
Siemens Healthineers AG Registration: 3002466018 View Registration
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Medical Device Recall: Z-0009-04

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer