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Lower risk Medical device recall · FDA · Published September 5, 2017

Forte Patient Positioning System Software Recalls: Communication Failures During Patient

Forte Automation Systems recalls patient positioning systems with specific software versions due to potential communication failures between the system and accuracy filter during patient procedures.

🇺🇸 FDA recall #Z-2537-2018Medical deviceForte Automation Systems ›
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Recalling firmForte Automation Systems Inc8155 Burden Rd · Machesney Park, IL 61115-8208
✎ GovInfoNow plain-language explainer

What happened, in plain English

Forte Automation Systems is recalling patient positioning systems with software versions 2.3.1 and 2.3.10. These systems may experience communication failures with the accuracy filter during patient procedures, which could affect treatment accuracy. Read more at govinfonow.com/recall/73068-forte-patient-positioning-system-software-recalls-communication-failures-during-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/73068-forte-patient-positioning-system-software-recalls-communication-failures-during-patient · Updated September 18, 2026 · FDA enforcement record: FDA #Z-2537-2018

Cite this page

“Forte Patient Positioning System Software Recalls: Communication Failures During Patient.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73068-forte-patient-positioning-system-software-recalls-communication-failures-during-patient. Based on FDA recall #Z-2537-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2537-2018%22&limit=1).

Why it’s dangerous

The system may experience periodic communication failures between the patient positioning system and the accuracy filter without clear warning to the operator. This could lead to inaccuracies in patient positioning during medical procedures.

Who’s affected

Medical facilities using patient positioning systems with the specified software versions are affected. Patients undergoing procedures requiring precise positioning are at risk of potential inaccuracies.

How to tell if you have this one

Check for software versions 2.3.1 or 2.3.10 on the KRC2 controller. The system uses a SCARA robotic arm for patient positioning in medical procedures.

  • Brand
    Forte Automation Systems
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Identify the software version on the KRC2 controller to determine if it is 2.3.1 or 2.3.10.

Where it went and when

Where it was distributed

Distributed in California.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “US in the state of California” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

1. Firm started the recall: Sep 5, 201712. FDA classified it Class II: Jul 24, 201823. Published in FDA’s Enforcement Report: Aug 1, 201834. FDA terminated the recall: Apr 13, 2020420172020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-2537-2018 (September 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2537-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA