Reported Dec 4, 2024 · Ongoing

Achieva TX Interventional Coil 3.0T

Philips North America LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289

Is this the product you have?

  • Achieva TX Interventional Coil 3.0T
Lot codes and dates
  • REF453530264711
  • UDI

    209 of 209 codes

    • 00884838066175
    • Serial No. 171
    • 318
    • 274
    • 333
    • 116
    • 120
    • 169
    • 177
    • 449
    • 430
    • 280
    • 460
    • 301
    • 287
    • 539
    • 460
    • 545
    • 182
    • 301
    • 502
    • 533
    • 109
    • 194
    • 178
    • 240
    • 198
    • 197
    • 223
    • 209
    • 204
    • 224
    • 93
    • 212
    • 341
    • 303
    • 237
    • 282
    • 298
    • 309
    • 268
    • 281
    • 297
    • 296
    • 312
    • 313
    • 326
    • 323
    • 325
    • 327
    • 345
    • 340
    • 350
    • 320
    • 346
    • 459
    • 358
    • 420
    • 495
    • 496
Amount recalled
5,231 units

This recall covers 13 products

The agency filed one notice per product. You are reading one of them; the other 12 are below.

Where it was sold

  • Nationwide

Why it was recalled

Potential safety issue where a patient may be harmed while preparing for or during a scan.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.