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Hyperfine Foam Head Pad
Hyperfine Operations, Inc. · Model 810-11108-00 · UDI-DI 00850043319047
IWY
Prescription
10
510(k) clearances
17
Adverse events (2 deaths)
1
Recalls
28
Facilities
Description
Memory foam cushion used as a support device to aid in the positioning of the patient’s head during an MRI procedure.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-06-05 | Brainlab AG | Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings a |
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