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Posirest 2

MEDTEC, INC. · Model 106522 · UDI-DI 00841439100356

IYE Prescription
1
510(k) clearances
3,073
Adverse events (20 deaths)
563
Recalls
115
Facilities

Description

Baseplate with headrest, high arm support, cranial arm support and rigid adjustable arm supports with large cups (2)

Recalls

DateFirmReason
2026-08-04PTW FREIBURGWhen a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorr
2026-06-16Accuray IncorporatedIn certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i
2026-06-16Accuray IncorporatedIn certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i
2026-05-21Elekta, Inc.Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
2025-12-14Elekta, Inc.Due to a manufacturing issue and electrical grounding of systems.
2025-12-10Elekta, Inc.Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or l
2025-10-09C-RAD POSITIONING ABDue to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the
2025-09-17ELEKTA SOLUTIONS ABWhen appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
2025-07-25Zap Surgical SystemsIf the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automat
2025-04-22C-RAD POSITIONING ABSoftware issue with scanning equipment that can results in the filed rotation not being applied correctly.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.