Facility

PIE MEDICAL IMAGING B.V.

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

Key facts

2recalls · worst Class II

—inspections in our data

—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)	3003595527
Establishment type	Manufacture Medical Device
Location	Demertdwarsstraat 8A01 MAASTRICHT Limburg, NL 6227 AK
Registration status	Active · expires 2026
Parent company	Pie Medical Imaging B.V. (owner-operator 9045579)
Brand names	CAAS Workstation

Activity by year

Recalls (2)

Devices registered here (2)

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Product code QHA (opens in a new tab) · Class II · Radiology · 21 CFR 892.1600
System, Image Processing, Radiological
Product code LLZ (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050

Recalls & enforcement

Class IIOngoing2026-05-07
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D …
Class IIOngoing2025-07-14
When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position wh…

All facilities operated by Pie Medical Imaging B.V.

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. “PIE MEDICAL IMAGING B.V. (FEI 3003595527) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003595527-pie-medical-imaging-b-v/

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