GE Healthcare Infinia II Systems Detector Fall Risk Recall
GE Healthcare recalls certain Infinia II and related nuclear medicine systems that may have been transported without proper detector support. This risk of detector fall could cause life-threatening bodily injury.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with risk-of-harm potential (life-threatening bodily injury from detector fall) but no reported illnesses or injuries to date. Per severity rubric, theoretical risk-of-harm products without reported injuries score at most 3.
Plain-English summary
GE Healthcare Infinia II and related nuclear medicine imaging systems are being recalled. Approximately 877 units distributed worldwide are affected, according to the manufacturer.
The systems may have been transported or relocated without proper detector support. This improper handling can result in excessive load being applied to the detector mounting mechanisms, potentially causing the detector to fall.
A detector fall could result in life-threatening bodily injury to nearby persons. To date, no injuries associated with this issue have been reported.
The recalled product
- Product
- GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Hazard
- detector-fall
- mounting-failure
- transport-damage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) H2799ZP: UDI/DI N/A
- System ID A5109665
- Serial Number 16611
- 2) H3000WT: UDI/DI N/A
- System ID 205408NUC
- Serial Number 17419
- UDI/DI N/A
- System ID 256341NRM1
- Serial Number 18226
- System ID 256494NM1
- Serial Number 17133
- System ID 256543INF1
- Serial Number 17182
- System ID 205408INF2
- Serial Number 18157
- System ID 256429INF1
- Serial Number 17557
- System ID 256327NUC
- Serial Number 17900
- System ID 334418INF
Distribution
Distribution scope not specified by the agency.
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