FDA Device Recall Z-0016-2014: Siemens Medical Solutions USA, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0016-2014.

Recall Res Number

Z-0016-2014

Recalling Firm / Manufacturer

Siemens Medical Solutions USA, Inc

FEI Number

2240869

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2013-05-06

Date Posted

2013-11-01

Date Terminated

2014-11-06

Product Code

OWB

Event Number

65161

Product Quantity

Product Description Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems

Reason for Recall Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; ho

Action Details Siemens initiated this correction on May 6, 2013 by sending Update InstructionXP005/13/S. Firm subsequently issued a letter on June 3, 2013 to all accounts. 1. Siemens Field Modification of the Luminos dRF, Ysio & Uroskop Omina running software versions VB10D, VB10F, VB10C and VB10E, which improves the signal transmission for the automatic exposure control, is available as of May 2013, and systems will be updated within one year. 2. The revised software fix for models Luminos dRF, Ysio & Uroskop Omina running software versions VB10D, VB10F, VB10C and VB10E, will be provided to all identified customers at no charge. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Siemens Medical Solutions USA, Inc., will notify the FDA district office in Philadelphia, Pennsylvania, with reports of progress regarding this field correction.

Distribution Pattern Nationwide Distribution

Code Information / Serial Numbers Material 10094910, with serial numbers 1036, 1045, 1025, 1040, 1041, 1032, 1047 and 1035; Material 10281013, with serial numbers 21221, 21223, 21213, 21089, 21098, 21163, 21171, 21194, 21212, 21186, 21188, 21167, 21187 and 21189; Material 10281163, with serial number 31114.

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Medical Device Recall: Z-0016-2014

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer