Reported Jul 10, 2024 · Ongoing
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal…
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
- Lot codes and dates
- Model No. 867246
- UDI
771 of 771 codes
00884838093195Serial No. DE67535433DE67535436DE67535443DE67535447DE67535452DE67535462DE67535463DE67535464DE67535470DE67535471DE67535474DE67535476DE67535479DE67535480DE67535483DE67535484DE67535487DE67535488DE67535499DE67535502DE67535507DE67535508DE67535518DE67535521DE67535523DE67535527DE67535529DE67535530DE67535533DE67535536DE67535538DE67535540DE67535542DE67535546DE67535547DE67535556DE67535562DE67535564DE67535566DE67535569DE67535570DE67535572DE67535574DE67535580DE67535581DE67535584DE67535587DE67535589DE67535591DE67535592DE67535598DE67535604DE67535605DE67535606DE67535623DE67535636DE67535646DE67535667DE67535711
- Amount recalled
- 6,915 units
Where it was sold
Why it was recalled
Potential for inaccurate fetal heart rate measurements when monitoring multiples.
This product could cause temporary or reversible health problems — stop using it.
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