Facility

C-RAD POSITIONING AB

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006621300
Establishment type	Manufacture Medical Device
Location	Sjukhusvagen 12K UPPSALA, SE 75309
Registration status	Active · expires 2026
Parent company	C-RAD Positioning AB (owner-operator 9096047)
Brand names	Sentinel; Sentinel 4DCT

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

Accelerator, Linear, Medical
Product code IYE (opens in a new tab) · Class II · Radiology · 21 CFR 892.5050

Recalls & enforcement

Class IIOngoing2025-10-09
Due 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 patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of t…
Class IIOngoing2025-04-22
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Class IITerminated2020-08-06
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step

FDA inspections (1)

VAI2018-07-19
Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by C-RAD Positioning AB

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “C-RAD POSITIONING AB (FEI 3006621300) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006621300-c-rad-positioning-ab/

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