FDA Device Recall Z-0034-05: Siemens Medical Solutions USA, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0034-05.

Recall Res Number

Z-0034-05

Recalling Firm / Manufacturer

Siemens Medical Solutions USA, Inc

FEI Number

2240869

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-07-09

Date Posted

2004-10-22

Date Terminated

2005-09-13

Product Code

DQK

Event Number

29826

Product Quantity

143 units

Product Description AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641

Reason for Recall possible error calculating valve area with the AXIOM Sensis

Action Details The recalling firm has issued a Customer Advisory to the affected customers per Update Instructions AX053/04/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.

Distribution Pattern The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.

Code Information / Serial Numbers Serial numbers: 4001-4008 and 4050-4056.

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Medical Device Recall: Z-0034-05

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer