- Recalling firm
- Foundation Medicine, Inc.
- Reason for recall
- Software issue that can cause an increase in spontaneous software closures.
- Affected products (lot / model / serial)
- Software Version: Protocol Configuration Tool (PCT) v2.0.0; Equipment ID: 100071, 100213, 100355, 102281, 103047, 104154, 104201, 104202, 104204, 104205, 104224, 104503, 104504, 104562, 104885, 105961, 106497, 00016, 00487, 00488, 00489, 00490, 00817, 00491, 00492, 00854, 01173, 01174, 01785, 01337, 01596, 01993.
- Units affected
- 32 units
- Distribution pattern
- US Nationwide distribution in the states of MA & NC.
- Firm location
- Cambridge, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2951-2026
- Recall initiated
- June 10, 2026
- FDA classification date
- August 14, 2026
- FDA report date
- August 26, 2026
- FDA event ID
- 99268
- Last updated on HTM Vibe
- September 8, 2026