Lower risk Medical device recall · FDA · Published January 24, 2018

Invivo DynaCad software recall: Incorrect PK and ADC maps after update 3.5

Invivo recalls DynaCad software updates 3.5 causing incorrect pharmacokinetic and diffusion maps. Users may underestimate critical medical values. No remedy stated.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1289-2018Medical device Invivo ›

Lower-risk recall

Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client. The defect causes the pharmacokinetic (PK) color maps to display incorrectly when viewed from remote DynaCAD client computers and could result in visually underestimating calculated Ktrans, Kep, and iAUGC values. The defect also impacts DynaCAD s on-the-fly calculation of Apparent Diffusion Coefficient (ADC) maps. If the ADC values are computed on-the-fly by DynaCAD, the ADC values and colors will also display incorrectly if viewed on a remote DynaCAD client.

Take action

Contact the company

Recalling firmInvivo Corporation3545 SW 47th Ave · Gainesville, FL 32608-7691

✎ GovInfoNow plain-language explainer

Invivo Corporation is recalling DynaCad software updates 3.5 due to incorrect display of pharmacokinetic and diffusion maps. This could lead to underestimating important medical values like Ktrans and ADC, potentially affecting diagnosis. Read more at govinfonow.com/recall/72105-invivo-dynacad-software-recall-incorrect-pk-and-adc-maps-after.

Source Summary by GovInfoNow · govinfonow.com/recall/72105-invivo-dynacad-software-recall-incorrect-pk-and-adc-maps-after · Updated August 28, 2026 · FDA enforcement record: FDA #Z-1289-2018

Cite this page

“Invivo DynaCad software recall: Incorrect PK and ADC maps after update 3.5.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/72105-invivo-dynacad-software-recall-incorrect-pk-and-adc-maps-after. Based on FDA recall #Z-1289-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1289-2018%22&limit=1).

The FDA announced on Jan. 24, 2018, that Invivo Corporation is recalling DynaCad software due to rendering defects in pharmacokinetic and diffusion coefficient maps. The agency classified the recall as Class II.

How to tell if you have it

Brand: Invivo
Product: DynaCad software (MR Analysis Server and viewer workstation)
Affected versions: v3.4, v3.5
Lot codes/Identifiers: DCAD1600760, DCAD1600796, DCAD1600860, DCAD1600879, DCAD1700886, DCAD1700891, DCAD1700905, DCAD1700913, DCAD1700913-1, DCAD1700913-2, DCAD1700913-3, DCAD1700913-4, DCAD1700913-5, DCAD1700928, DCAD1700930

The hazard

Following an update from version 3.3 to 3.5, the Ktrans map was not rendered correctly on the DynaCad Client. The defect causes pharmacokinetic (PK) color maps to display incorrectly when viewed from remote DynaCAD client computers and could result in visually underestimating calculated Ktrans, Kep, and iAUGC values. The defect also impacts DynaCAD's on-the-fly calculation of Apparent Diffusion Coefficient (ADC) maps, causing ADC values and colors to display incorrectly if computed on-the-fly.

Context

GovInfoNow's records show Invivo Corporation has 8 other recalls on record since 2017-08-11. On 2020-09-14, the company recalled MR Coils because incorrect water rating labels may cause damage. On 2020-02-06, Invivo issued a recall for monitors due to insufficient shielding risks. Another recall on 2018-09-24 involved Xper Flex Cardio Physiomonitoring Software where invasive blood pressure values may freeze.

How to tell if you have this one

Check if you updated DynaCad software from version 3.3 to 3.5. The affected software includes DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK modules.

Brand
Invivo
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your DynaCad software version to see if it has been updated from 3.3 to 3.5.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

Jan 24, 2018Firm started the recall
Apr 2, 2018FDA classified it Class II
Apr 11, 2018Published in FDA’s Enforcement Report
May 4, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Invivo recalls

Link to this recall

<a href="https://govinfonow.com/recall/72105-invivo-dynacad-software-recall-incorrect-pk-and-adc-maps-after">Invivo DynaCad software recall: Incorrect PK and ADC maps after update 3.5 (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1289-2018 (January 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1289-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.