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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98102

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 14, 2022
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Philips Ultrasound, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122

Z-1007-2026
Recall number
Z-1007-2026
Initiated
July 14, 2022
Classification
Class II
Status
Completed
Recalling firm
Philips Ultrasound, LLC
Quantity
1,721 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

Code information

Software Version Numbers: 9.0, 9.01, 9.02 795234/UDI: (01)00884838107540 795232/UDI: (01)00884838107533 795231/ UDI: (01)00884838097933 795201/UDI: (01)00884838047693 795200/ UDI: (01)00884838107441 795122/ UDI: (01)00884838097933 795117/ UDI: (01)00884838047693

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Korea, Republic of Latvia, Lithuania, Morocco, Netherlands , New Zealand, Oman, Panama, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom.