Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201,
FDA device recall Z-1007-2026 · posted 2025-12-31 · Completed
Recall details
- Recalling firm
- Philips Ultrasound, LLC
- Reason for recall
- Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
- Action taken
- On July 18, 2022, Phillips issued a product notification to affected consignees. Philips ask consignees to take the following actions: 1. If the X5-1c transducer is connected to the right-most port (when viewing from the front), this problem will not occur. Please ensure your X5-1c is connected to the right-most connector until the software update (FCO79500561) has been installed. 2. Please retain this letter with your product documentation until the software update (FCO79500561) has been implemented on your system. 3. Please circulate this notice to all users of this device so that they are aware of the issue. 4. A Philips Field Service Engineer will contact you to schedule the installation of the software update to resolve this issue (reference FCO79500561).
- Root cause
- Software Design Change
- Status
- Completed
- Product code
- IYN
- Quantity affected
- 1,721 systems
- Distribution
- 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,
- Date initiated
- 2022-07-14
- Date posted
- 2025-12-31
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EPIQ Series Diagnostic Ultrasound System (K231190) | Philips Ultrasound, LLC | 2023-05-12 |