HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR…
Medical device recall Z-1950-2024. Published in FDA’s Enforcement Report on Jun 12, 2024.
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 Jun 12, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 590 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?
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
590 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: (01)00884838099500(21) Serial Numbers: 100018 100019 100020 100023 100024 100025 100026 100027 100028 100029 100030 100031 100032 100033 100034 100036 100038 100039 100041 100042 100043 100044 100045 100046 100047 100048 100049 100050…
Every code shown here, 1,997 characters
UDI: (01)00884838099500(21) Serial Numbers: 100018 100019 100020 100023 100024 100025 100026 100027 100028 100029 100030 100031 100032 100033 100034 100036 100038 100039 100041 100042 100043 100044 100045 100046 100047 100048 100049 100050 100051 100053 100054 100056 100057 100058 100059 100060 100062 100063 100064 100066 100067 100068 100069 100071 100072 100073 100074 100075 100076 100077 100078 100079 100080 100081 100083 100084 100085 100086 100087 100089 100090 100091 100092 100093 100094 100095 100096 100097 100098 100099 100100 100102 100103 100104 100105 100106 100107 100108 100109 100110 100111 100112 100113 100114 100115 100116 100117 100118 100119 100120 100121 100122 100123 100124 100125 100126 100127 100129 100130 100131 100133 100134 100135 100136 100137 100138 100140 100141 100143 100144 100145 100146 100148 100149 100150 100152 100153 100154 100155 100156 100157 100158 100159 100161 100164 100165 100166 100167 100170 100171 100172 100174 100175 100176 100177 100178 100179 100180 100181 100182 100183 100185 100186 100189 100190 100191 100192 100193 100194 100195 100197 100199 100200 100201 100202 100203 100204 100205 100206 100207 100209 100210 100211 100212 100213 100215 100216 100218 100220 100221 100222 100223 100224 100225 100226 100228 100232 100234 100235 100236 100237 100238 100239 100243 100244 100245 100246 100247 100248 100249 100250 100251 100252 100253 100254 100255 100256 100257 100258 100260 100262 100263 100264 100265 100266 100267 100268 100269 100271 100272 100273 100274 100275 100277 100278 100279 100282 100283 100284 100285 100287 100288 100289 100290 100291 100292 100293 100294 100295 100296 100297 100298 100299 100300 100301 100302 100303 100305 100306 100309 100310 100311 100312 100314 100316 100320 100322 100323 100324 100325 100326 100328 100329 100332 100336 100337 100339 100340 100342 100343 100345 100347 100351 100352 100353 100355 100356 100357 100358 100360 100361 100362 100363 100364 100366 100367 100368 100369 100370…
FDA’s list runs to 4,173 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 and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Fiji, Finland, France, French Guiana, Germany, Guadeloupe, Honduras, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, Oman, Peru, Poland, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 May 3, 2024.
- FDA classified it on Jun 4, 2024.
- FDA’s Enforcement Report published it on Jun 12, 2024.
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 4,173 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.