Ingenia Ambition S-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: 781359

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Number Unique Device Identifier (UDI#) 48026 (01)00884838090057(21)48026 48016 (01)00884838090057(21)48016 48053 (01)00884838090057(21)48053 48003 (01)00884838090057(21)48003 48136 (01)00884838090057(21)48136 48144 (01)00884838090057(21)48144 48020 (01)00884838090057(21)48020 48155 (01)00884838090057(21)48155 48191 (01)00884838090057(21)48191 48216 (01)00884838090057(21)48216 48124 (01)00884838090057(21)48124 48030 (01)00884838090057(21)48030 48011 (01)00884838090057(21)48011 48183 (01)00884838090057(21)48183 48186 (01)00884838090057(21)48186 48187 (01)00884838090057(21)48187 48234 (01)00884838090057(21)48234 48051 (01)00884838090057(21)48051 48000 (01)00884838090057(21)48000 48004 (01)00884838090057(21)48004 48009 (01)00884838090057(21)48009 48005 (01)00884838090057(21)48005 48019 (01)00884838090057(21)48019 48032 (01)00884838090057(21)48032 48132 (01)00884838090057(21)48132 48224 (01)00884838090057(21)48224 48223 (01)00884838090057(21)48223 48207 (01)00884838090057(21)48207 48015 (01)00884838090057(21)48015 48028 N/A 48154 N/A 48160 N/A 48134 N/A 48049 N/A 48031 N/A 48050 N/A 48131 N/A 48040 (01)00884838090057(21)48040 48039 (01)00884838090057(21)48039 48152 (01)00884838090057(21)48152 48173 (01)00884838090057(21)48173 48122 (01)00884838090057(21)48122 48022 (01)00884838090057(21)48022 48012 (01)00884838090057(21)48012 48014 (01)00884838090057(21)48014 48037 (01)00884838090057(21)48037 48036 (01)00884838090057(21)48036 48158 (01)00884838090057(21)48158 48127 (01)00884838090057(21)48127 48044 (01)00884838090057(21)48044 48184 (01)00884838090057(21)48184 48151 (01)00884838090057(21)48151 48174 (01)00884838090057(21)48174 48043 (01)00884838090057(21)48043 48046 (01)00884838090057(21)48046 48055 (01)00884838090057(21)48055 48047 (01)00884838090057(21)48047 48128 (01)00884838090057(21)48128 48129 (01)00884838090057(21)48129 48180 (01)00884838090057(21)48180 48192 (01)00884838090057(21)48192 48194 (01)00884838090057(21)48194 48153 (01)00884838090057(21)48153 48190 (01)00884838090057(21)48190 48226 (01)00884838090057(21)48226 48045 (01)00884838090057(21)48045 48033 N/A 48023 (01)00884838090057(21)48023 48181 (01)00884838090057(21)48181 48200 (01)00884838090057(21)48200 48199 (01)00884838090057(21)48199 48198 N/A 48001 (01)00884838090057(21)48001 48038 (01)00884838090057(21)48038 48167 (01)00884838090057(21)48167 48196 (01)00884838090057(21)48196 48034 (01)00884838090057(21)48034 48035 (01)00884838090057(21)48035 48172 (01)00884838090057(21)48172 48010 (01)00884838090057(21)48010 48027 N/A 48169 (01)00884838090057(21)48169 48182 (01)00884838090057(21)48182 48148 (01)00884838090057(21)48148 48188 (01)00884838090057(21)48188 48018 (01)00884838090057(21)48018 48017 (01)00884838090057(21)48017 48056 (01)00884838090057(21)48056 48112 (01)00884838090057(21)48112 48052 (01)00884838090057(21)48052 48130 (01)00884838090057(21)48130 48013 (01)00884838090057(21)48013 48162 (01)00884838090057(21)48162 48120 (01)00884838090057(21)48120 48171 (01)00884838090057(21)48171 48166 (01)00884838090057(21)48166 48179 (01)00884838090057(21)48179 48214 (01)00884838090057(21)48214 48133 (01)00884838090057(21)48133
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips North America Llc
Reason for Recall:
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
completed

Product Information

Full Description:

Ingenia Ambition S-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: 781359

Product Codes/Lot Numbers:

Serial Number Unique Device Identifier (UDI#) 48026 (01)00884838090057(21)48026 48016 (01)00884838090057(21)48016 48053 (01)00884838090057(21)48053 48003 (01)00884838090057(21)48003 48136 (01)00884838090057(21)48136 48144 (01)00884838090057(21)48144 48020 (01)00884838090057(21)48020 48155 (01)00884838090057(21)48155 48191 (01)00884838090057(21)48191 48216 (01)00884838090057(21)48216 48124 (01)00884838090057(21)48124 48030 (01)00884838090057(21)48030 48011 (01)00884838090057(21)48011 48183 (01)00884838090057(21)48183 48186 (01)00884838090057(21)48186 48187 (01)00884838090057(21)48187 48234 (01)00884838090057(21)48234 48051 (01)00884838090057(21)48051 48000 (01)00884838090057(21)48000 48004 (01)00884838090057(21)48004 48009 (01)00884838090057(21)48009 48005 (01)00884838090057(21)48005 48019 (01)00884838090057(21)48019 48032 (01)00884838090057(21)48032 48132 (01)00884838090057(21)48132 48224 (01)00884838090057(21)48224 48223 (01)00884838090057(21)48223 48207 (01)00884838090057(21)48207 48015 (01)00884838090057(21)48015 48028 N/A 48154 N/A 48160 N/A 48134 N/A 48049 N/A 48031 N/A 48050 N/A 48131 N/A 48040 (01)00884838090057(21)48040 48039 (01)00884838090057(21)48039 48152 (01)00884838090057(21)48152 48173 (01)00884838090057(21)48173 48122 (01)00884838090057(21)48122 48022 (01)00884838090057(21)48022 48012 (01)00884838090057(21)48012 48014 (01)00884838090057(21)48014 48037 (01)00884838090057(21)48037 48036 (01)00884838090057(21)48036 48158 (01)00884838090057(21)48158 48127 (01)00884838090057(21)48127 48044 (01)00884838090057(21)48044 48184 (01)00884838090057(21)48184 48151 (01)00884838090057(21)48151 48174 (01)00884838090057(21)48174 48043 (01)00884838090057(21)48043 48046 (01)00884838090057(21)48046 48055 (01)00884838090057(21)48055 48047 (01)00884838090057(21)48047 48128 (01)00884838090057(21)48128 48129 (01)00884838090057(21)48129 48180 (01)00884838090057(21)48180 48192 (01)00884838090057(21)48192 48194 (01)00884838090057(21)48194 48153 (01)00884838090057(21)48153 48190 (01)00884838090057(21)48190 48226 (01)00884838090057(21)48226 48045 (01)00884838090057(21)48045 48033 N/A 48023 (01)00884838090057(21)48023 48181 (01)00884838090057(21)48181 48200 (01)00884838090057(21)48200 48199 (01)00884838090057(21)48199 48198 N/A 48001 (01)00884838090057(21)48001 48038 (01)00884838090057(21)48038 48167 (01)00884838090057(21)48167 48196 (01)00884838090057(21)48196 48034 (01)00884838090057(21)48034 48035 (01)00884838090057(21)48035 48172 (01)00884838090057(21)48172 48010 (01)00884838090057(21)48010 48027 N/A 48169 (01)00884838090057(21)48169 48182 (01)00884838090057(21)48182 48148 (01)00884838090057(21)48148 48188 (01)00884838090057(21)48188 48018 (01)00884838090057(21)48018 48017 (01)00884838090057(21)48017 48056 (01)00884838090057(21)48056 48112 (01)00884838090057(21)48112 48052 (01)00884838090057(21)48052 48130 (01)00884838090057(21)48130 48013 (01)00884838090057(21)48013 48162 (01)00884838090057(21)48162 48120 (01)00884838090057(21)48120 48171 (01)00884838090057(21)48171 48166 (01)00884838090057(21)48166 48179 (01)00884838090057(21)48179 48214 (01)00884838090057(21)48214 48133 (01)00884838090057(21)48133

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2416-2021

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