Phi 150 Flex coil · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2016-04-14	Z-2135-2016	Class II	Terminated	A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.Distribution: US Nationwide Distribution	33 units	clearance family

Regulatory clearances

510(k)K152371Substantially equivalent (SESE) · 2015-10-23clearance family

Predicate lineage

K152371
- K143008
  - K132160
    - K120487

Cited as predicate by: K160632, K162183, K172878, K182282

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility
2014-09-19	NAI	No action indicated	Canon Components, Inc. (Factory Site)
2014-09-17	NAI	No action indicated	Canon Inc.
2014-09-17	NAI	No action indicated	Canon Inc.

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