- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Reason for recall
- Potential of failing to trigger clinical scan during Bolus Tracking.
- Affected products (lot / model / serial)
- Device Identifier: (01)00884838085015, (01)00884838105508.
- Units affected
- N/A
- Distribution pattern
- U.S. Nationwide and U.S. Territories distribution.
- Firm location
- Suzhou, N/A, China
- Recall type
- FDA Mandated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2988-2026
- Recall initiated
- June 26, 2026
- FDA classification date
- August 21, 2026
- FDA report date
- September 2, 2026
- FDA event ID
- 99511
- Last updated on HTM Vibe
- September 8, 2026