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 Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.) and recall number Z-1959-2026, 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.

Recall Record: Class II Recall: Philips Ingenia 3.0T CX with MR Elastography (MRE).… by Philips North America

At a glance: Philips North America recalled Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808. on 2026-05-06. FDA classified this action as a Class II recall (recall number Z-1959-2026). Reason for recall: 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.. Recall status: Ongoing. This is a device-category FDA recall record.

Key facts

Recalling firm	Philips North America
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
Classification	Class II
Recall number	Z-1959-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	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.

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 Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808. -- and the recall number Z-1959-2026. 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.

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 Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.. 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-1959-2026 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 was recalled and why?: Philips North America recalled Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.. FDA's record states the reason for recall as: 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 logged under FDA recall number.
How serious is this recall?: 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.
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 Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.) and recall number Z-1959-2026, 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.

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Full FDA history for Philips North America

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class II Recall: Philips Ingenia 3.0T CX with MR Elastography (MRE).… by Philips North America. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-philips-north-america-z-1959-2026

MLA

"Recall Record: Class II Recall: Philips Ingenia 3.0T CX with MR Elastography (MRE).… by Philips North America." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-philips-north-america-z-1959-2026.

Chicago

Argus HQ Research. "Recall Record: Class II Recall: Philips Ingenia 3.0T CX with MR Elastography (MRE).… by Philips North America." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-philips-north-america-z-1959-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_philips_north_america_z_1959_2026_2026,
  title = {Recall Record: Class II Recall: Philips Ingenia 3.0T CX with MR Elastography (MRE).… by Philips North America},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-philips-north-america-z-1959-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗