Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D01137

FDA device recall Z-1886-2016 · posted 2016-06-01 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics Inc.

Reason for recall

Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.

Action taken

Siemens sent an Urgent Medical Device Correction letter dated March 24, 2016, to all affected customers. Customers were advised to follow the instructions contained in the "Urgent Medical Device Correction" notification letter to help minimize or eliminate the impact that this specific software defect could cause until a software correction could be made (i.e instructions to minimize the impact of the software defect due to "Bad Sample Detect " False Transition" errors when processing front loaded samples) and (how to eliminate the impact of the software defect when processing front loaded samples). Customers were also asked to review the recall notification letter with their Medical Director and complete and return the Field Correction Effectiveness Check Form within 30 days. Customers with questions were advised to contact Siemens Customer Care Center - Technical Solutions at 800-441-9250 or their local Siemens technical support representative. For questions regarding this recall call 302-631-8248.

Root cause

Software design

Status

Terminated

Product code

JJE

Quantity affected

1300

Distribution

Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, , ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA,

Date initiated

2016-03-24

Date posted

2016-06-01

Date terminated

2017-03-13

Location

Brookfield, CT

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