FDA Class II Recall: Philips SmartPath to dStream for 1.5T with MR… by Philips North America

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112. -- and the recall number Z-1965-2026. If it matches, stop using or distributing it and contact Philips North America or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Philips North America and the affected product is described in FDA's record as: Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.. FDA's stated reason for the recall is: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.. The recall is tracked under FDA recall number Z-1965-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

Philips North America’s FDA history

Argus HQ has recorded 19 total FDA actions tied to Philips North America: 0 warning letters, 19 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.) and recall number Z-1965-2026, then follow Philips North America's recall instructions.

Has Philips North America had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 19 total FDA actions tied to Philips North America, including 19 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-1965-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

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