The Recall Desk

Manufacturer

NeoCoil, LLC

2 recalls in our database name NeoCoil, LLC as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
1
Most recent
2016-08-10

Of the 2 recalls from NeoCoil, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-2312-2016·2016-08-10

    NeoCoil 3T 16ch Flex SPEEDER Large Coil Recalled for Surface Temperature Risk

    NeoCoil, LLC is recalling 39 units of the 3T 16ch Flex SPEEDER Large Coil due to a potential for higher than specified surface temperatures.

    Product
    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor e
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1027-2016·2016-03-09

    NeoCoil 3.0T GEM Flex Coil Recalled for Potential Burn Risk

    NeoCoil, LLC is recalling 2,121 units of the 3.0T GEM Flex Coil system due to a potential for higher than specified surface temperatures that may result in patient warming or burns.

    Product
    NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2.
    Category
    Medical Device
    Distribution
    Distributed nationwide