Food, drugs, devices › Philips Medical Systems North America Inc.
Device recall: EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analys
FDA enforcement event 66662 is a device recall by Philips Medical Systems North America Inc. of Bothell, WA, initiated 17 Oct 2013 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 16 Jul 2014. Initiation: voluntary: firm initiated. Philips Medical Systems North America Inc. has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Medical Systems North America Inc., Bothell, WA.
Reason for recall
"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)."
Distribution
"Worldwide Distribution-USA (nationwide) including the states of CT, HI, IL, IN, KY, MA, ME, MI, NC, OR, PA, TX, and WA, and the countries of Australia, Austria, Belgium, Chile, Denmark, Finland,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0368-2014 | EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis. | 306 units total (206 international; 100 in the US). | Class II | Terminated | 27 Nov 2013 |
Context
Other enforcement events for Philips Medical Systems North America Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 Feb 2014 | Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue nu | Device | Class II | 2 |
| 6 Feb 2014 | Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M50 | Device | Class II | 1 |
| 6 Feb 2014 | Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery | Device | Class II | 1 |
All 4 events for Philips Medical Systems North America Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution-USA (nationwide) including the states of CT, HI, IL, IN, KY, MA, ME, MI, NC, OR, PA, TX, and WA, and the countries of Australia, Austria, Belgium, Chile, Denmark, Finland,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Jul 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.