Philips recalls specific MRI systems with software versions R11.1 and R12.1 due to potential stiffness value errors in exported MR Elastography scans. Affected units may need software updates to prevent inaccurate imaging results.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips is recalling certain MRI systems that could produce incorrect stiffness measurements in scans. This might lead to inaccurate medical diagnoses if the errors go unnoticed.
The software versions R11.1 and R12.1 can cause stiffness value errors when exporting MR Elastography (MRE) scans to PACS systems. This might result in incorrect tissue stiffness measurements, potentially affecting diagnosis accuracy.
MRI system users and healthcare providers who operate the recalled Philips SmartPath to dStream systems with software versions R11.1 or R12.1. Patients receiving scans on these systems may be at risk of inaccurate results.
Check if your Philips SmartPath to dStream MRI system has software version R11.1 or R12.1. Product code 781270 and serial numbers 24066, 38113, or 17356 indicate affected units.
Verify your MRI system's software version to see if it is R11.1 or R12.1.
No, the recall does not require immediate discontinuation. Affected systems can continue to be used but may need software updates.
Contact Philips North America directly to confirm your system's status and receive guidance on software updates.
The recall addresses potential inaccuracies in scan results, not direct physical harm. Serious injury is not mentioned as a risk.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1216-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-1216-2026 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.