Reported Nov 27, 2013 · Terminated

EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow…

Philips Medical Systems North America Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Medical Systems North America Inc. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431

Is this the product you have?

  • EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Lot codes and dates
  • TRACE ITEM
  • SERIAL NUMBERS in the UNITED STATES

    101 of 101 codes

    • US713B0171
    • US713B0207
    • US813B0017
    • US813B0018
    • US813B0019
    • US813B0020
    • US813B0022
    • US813B0023
    • US813B0024
    • US813B0025
    • US813B0122
    • US813B0123
    • US813B0125
    • US813B0127
    • US813B0128
    • US813B0129
    • US813B0131
    • US813B0132
    • US813B0134
    • US813B0135
    • US813B0233
    • US813B0234
    • US813B0235
    • US813B0236
    • US813B0237
    • US813B0238
    • US813B0239
    • US813B0240
    • US813B0423
    • US813B0424
    • US813B0425
    • US813B0426
    • US813B0427
    • US813B0428
    • US813B0429
    • US813B0430
    • US813B0431
    • US813B0432
    • US813B0433
    • US813B0434
    • US913B0033
    • US913B0034
    • US913B0035
    • US913B0036
    • US913B0037
    • US913B0038
    • US913B0039
    • US913B0040
    • US913B0057
    • US913B0060
    • US913B0061
    • US913B0062
    • US913B0063
    • US913B0064
    • US913B0065
    • US913B0066
    • US913B0106
    • US913B0107
    • US913B0108
    • US913B0109
  • TRACE ITEM SERIAL NUMBERS INTERNATIONAL

    206 of 206 codes

    • US513B0224
    • US513B0295
    • US513B0387
    • US513B0560
    • US613B0299
    • US713B0085
    • US713B0086
    • US713B0118
    • US713B0119
    • US713B0120
    • US713B0122
    • US713B0123
    • US713B0126
    • US713B0149
    • US713B0171
    • US713B0172
    • US713B0192
    • US713B0193
    • US713B0194
    • US713B0195
    • US713B0204
    • US713B0205
    • US713B0206
    • US713B0208
    • US713B0324
    • US713B0325
    • US713B0358
    • US713B0359
    • US713B0437
    • US713B0439
    • US713B0440
    • US713B0532
    • US713B0537
    • US713B0573
    • US713B0574
    • US713B0575
    • US713B0576
    • US713B0577
    • US713B0578
    • US713B0579
    • US713B0580
    • US713B0581
    • US713B0582
    • US713B0583
    • US713B0584
    • US713B0586
    • US713B0587
    • US713B0588
    • US713B0589
    • US713B0590
    • US713B0592
    • US713B0593
    • US713B0594
    • US713B0595
    • US813B0015
    • US813B0016
    • US813B0032
    • US813B0037
    • US813B0038
    • US813B0039
Amount recalled
306 units total (206 international; 100 in the US).

Where it was sold

Why it was recalled

A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 16, 2014 · Data as of Sep 19, 4:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.