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.
2 linked reportsMalfunction 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 6.74 |
| 2019-02 | 0 | 6.9 |
| 2019-03 | 0 | 6.68 |
| 2019-04 | 0 | 8.56 |
| 2019-05 | 0 | 8.85 |
| 2019-06 | 0 | 7.17 |
| 2019-07 | 0 | 7.14 |
| 2019-08 | 0 | 12.27 |
| 2019-09 | 0 | 6.67 |
| 2019-10 | 0 | 5.61 |
| 2019-11 | 0 | 6.15 |
| 2019-12 | 0 | 7.32 |
| 2020-01 | 0 | 4.59 |
| 2020-02 | 0 | 6.89 |
| 2020-03 | 0 | 8.19 |
| 2020-04 | 0 | 11.12 |
| 2020-05 | 0 | 5.26 |
| 2020-06 | 0 | 4.63 |
| 2020-07 | 0 | 4.29 |
| 2020-08 | 0 | 3.71 |
| 2020-09 | 0 | 3.14 |
| 2020-10 | 0 | 3.96 |
| 2020-11 | 0 | 3.51 |
| 2020-12 | 0 | 3.86 |
| 2021-01 | 0 | 3.48 |
| 2021-02 | 0 | 4 |
| 2021-03 | 0 | 4.16 |
| 2021-04 | 0 | 4.85 |
| 2021-05 | 0 | 4.98 |
| 2021-06 | 0 | 5.75 |
| 2021-07 | 0 | 4.23 |
| 2021-08 | 0 | 5.94 |
| 2021-09 | 0 | 6.69 |
| 2021-10 | 0 | 5.3 |
| 2021-11 | 0 | 5.82 |
| 2021-12 | 0 | 5.89 |
| 2022-01 | 0 | 4.85 |
| 2022-02 | 0 | 4.79 |
| 2022-03 | 0 | 5.61 |
| 2022-04 | 0 | 5.1 |
| 2022-05 | 0 | 7.18 |
| 2022-06 | 0 | 5.01 |
| 2022-07 | 0 | 5.46 |
| 2022-08 | 0 | 5.26 |
| 2022-09 | 0 | 5.44 |
| 2022-10 | 0 | 17.06 |
| 2022-11 | 0 | 31 |
| 2022-12 | 0 | 27.35 |
| 2023-01 | 0 | 37.29 |
| 2023-02 | 0 | 23.29 |
| 2023-03 | 0 | 44.83 |
| 2023-04 | 0 | 27.6 |
| 2023-05 | 0 | 32.13 |
| 2023-06 | 0 | 26.04 |
| 2023-07 | 0 | 18.81 |
| 2023-08 | 0 | 21.75 |
| 2023-09 | 0 | 28.29 |
| 2023-10 | 0 | 27.89 |
| 2023-11 | 0 | 30.51 |
| 2023-12 | 0 | 28.19 |
| 2024-01 | 0 | 31.2 |
| 2024-02 | 0 | 42.01 |
| 2024-03 | 0 | 27.23 |
| 2024-04 | 0 | 25.39 |
| 2024-05 | 0 | 24.7 |
| 2024-06 | 0 | 24.04 |
| 2024-07 | 0 | 27.28 |
| 2024-08 | 0 | 34.59 |
| 2024-09 | 0 | 34.34 |
| 2024-10 | 0 | 30 |
| 2024-11 | 0 | 27.77 |
| 2024-12 | 0 | 28.67 |
| 2025-01 | 0 | 26.52 |
| 2025-02 | 0 | 37.34 |
| 2025-03 | 0 | 23.81 |
| 2025-04 | 0 | 41.17 |
| 2025-05 | 0 | 40.57 |
| 2025-06 | 0 | 39.81 |
| 2025-07 | 0 | 41.93 |
| 2025-08 | 0 | 62.1 |
| 2025-09 | 0 | 98.45 |
| 2025-10 | 0 | 96.94 |
| 2025-11 | 0 | 63 |
| 2025-12 | 2 | 23.76 |
| 2026-01 | 0 | 25.19 |
| 2026-02 | 0 | 18.06 |
| 2026-03 | 0 | 23.52 |
| 2026-04 | 0 | 18.46 |
| 2026-05 | 0 | 22.25 |
| 2026-06 | 0 | 17.53 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-01-02 | Z-1152-2024 | Class II | Open, Classified | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.Distribution: Worldwide Distribution: US nationwide including states of: AL, AK, 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, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and OUS (International) to countries of: Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, and Yemen. | 13, 133 (3,408 US; 9,725 ROW) | code info di |
| 2024-01-02 | Z-1145-2024 | Class II | Open, Classified | Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.Distribution: Worldwide - US Nationwide distribution. | 1,993 US; 2,662 ROW | code info di |
| 2023-12-12 | Z-0835-2024 | Class II | Open, Classified | System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.Distribution: Worldwide - US Nationwide distribution. | 1,799 US; 5,747 OUS | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-12-09 | 3003768277-2025-015628 | Malfunction | Available | catalog number |
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-01-17 | OAI | Official action indicated | Philips Medical Systems Nederland B.V. | 0 |
| 2023-01-26 | OAI | Official action indicated | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 3 |
| 2010-09-21 | NAI | No action indicated | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 0 |
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