SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a…
Medical device recall Z-2415-2021. Published in FDA’s Enforcement Report on Sep 15, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 15, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Completed its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 566 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260
566 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number Unique Device Identifier (UDI#) 8750 N/A 32245 N/A 9013 N/A 8554 N/A 20211 N/A 18801 N/A 8178 N/A 10164 N/A 8752 N/A 10139 N/A 11076 N/A 8156 N/A 8646 N/A 22116 N/A 21175 N/A 8118 N/A 32443 N/A 32444 N/A 32445 N/A 18561 N/A…
Every code shown here, 1,992 characters
Serial Number Unique Device Identifier (UDI#) 8750 N/A 32245 N/A 9013 N/A 8554 N/A 20211 N/A 18801 N/A 8178 N/A 10164 N/A 8752 N/A 10139 N/A 11076 N/A 8156 N/A 8646 N/A 22116 N/A 21175 N/A 8118 N/A 32443 N/A 32444 N/A 32445 N/A 18561 N/A 18761 N/A 30037 N/A 30146 N/A 21748 N/A 20003 N/A 21384 N/A 20116 N/A 20115 N/A 33220 N/A 18746 (01)00884838095076 8074 (01)00884838095076 18853 (01)00884838095076 21349 (01)00884838095076 18986 (01)00884838095076 18943 (01)00884838095076 18583 (01)00884838095076 22144 (01)00884838095076 22266 (01)00884838095076(21)22266 33045 (01)00884838095076(21)33045 32262 (01)00884838095076(21)32262 11100 (01)00884838095076(21)11100 5572 N/A 10236 N/A 12030 N/A 10183 N/A 72077 N/A 8985 N/A 21466 N/A 8240 N/A 32643 N/A 12084 N/A 8260 N/A 8942 N/A 21912 N/A 32180 N/A 21736 N/A 32059 (01)00884838095076 8917 N/A 10087 N/A 8713 N/A 10130 N/A 32621 N/A 18673 N/A 18701 N/A 30067 N/A 21775 (01)00884838095076 21679 N/A 32086 N/A 22220 N/A 8001 N/A 20070 N/A 10717 N/A 39103 N/A 5523 N/A 10511 N/A 10170 N/A 8642 N/A 21033 N/A 11030 N/A 10061 N/A 11031 N/A 8318 N/A 10174 N/A 18665 N/A 8611 N/A 8084 N/A 10191 N/A 8387 N/A 21932 N/A 8025 N/A 18644 N/A 5463 N/A 21142 N/A 8559 N/A 20057 N/A 11102 N/A 18631 N/A 8804 N/A 18565 N/A 5447 N/A 21015 N/A 10075 N/A 11062 N/A 30045 N/A 32176 N/A 8407 N/A 8512 N/A 8021 N/A 32752 N/A 21676 N/A 11001 N/A 18697 N/A 32710 N/A 32438 N/A 21171 N/A 39031 N/A 10033 N/A 5539 N/A 32636 N/A 21392 N/A 8129 N/A 8397 N/A 11108 N/A 11000 N/A 8704 N/A 13082 N/A 10179 N/A 8263 N/A 10523 N/A 32092 N/A 32113 N/A 32341 N/A 32334 N/A 8110 N/A 18957 N/A 8487 N/A 18938 N/A 32454 N/A 12082 N/A 9020 (01)00884838095076 9024 (01)00884838095076 8736 (01)00884838095076 8885 (01)00884838095076 22194 (01)00884838095076 21018 (01)00884838095076 21814 (01)00884838095076 5484 (01)00884838095076 10117 (01)00884838095076 8476 (01)00884838095076 30097 (01)00884838095076 8315 (01)00884838095076 32163 (01)00884838095076 32099 (01)00884838095076 8401…
FDA’s list runs to 7,462 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People’s Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Completed, in FDA’s file.
“The recall action reaches the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.”
openFDA, on “Completed”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 11, 2021.
- FDA classified it on Sep 3, 2021.
- FDA’s Enforcement Report published it on Sep 15, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America Llc, of Cambridge, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,462 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.