Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-10-31 | Z-0883-2026 | Class II | Open, Classified | Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.Distribution: Worldwide US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Dominican Rep, Ecuador, El Salvador, Estonia, France, Germany, Greece, Guatemala, Honduras , Hungary, Iceland, India, Indonesia, Israel, Italy, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Singapore, Slovakia, South Africa, South Korea, Spain, St. Pier/Miquel., Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Tunisia, T¿rkiye, United Kingdom, Uruguay, Vietnam. | 4,819 systems | clearance family |
| 2025-07-03 | Z-2374-2025 | Class III | Open, Classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Distribution: US Nationwide distribution. | 171,322 units | clearance family |
| 2025-07-03 | Z-2392-2025 | Class III | Open, Classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Distribution: US Nationwide distribution. | 171,322 units | clearance family |
Regulatory clearances
- 510(k)K203406Substantially equivalent (SESE) · 2021-02-23clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-09-09 | WL | Warning Letter | Philips Ultrasound, Inc | — |
| 2025-03-13 | OAI | Official action indicated | Philips Ultrasound, Inc | 4 |
| 2025-01-31 | OAI | Official action indicated | Philips Ultrasound, LLC | 6 |
| 2024-08-08 | VAI | Voluntary action indicated | Philips Ultrasound, Inc. | 0 |
| 2021-11-10 | NAI | No action indicated | Philips Ultrasound, LLC | 0 |
| 2012-09-05 | NAI | No action indicated | Philips Ultrasound, Inc | 0 |
| 2011-12-09 | VAI | Voluntary action indicated | Philips Ultrasound, LLC | 4 |
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