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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens Medical Solutions USA, Inc: Siemens X-Ray Systems Recalled for Falling Support Arm Risk

Agency Publication Date: August 7, 2024
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Summary

Siemens Medical Solutions USA, Inc. has recalled approximately 383 medical imaging systems, including the Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max. These diagnostic x-ray machines are used by healthcare professionals to visualize anatomical structures. The recall was initiated because the support arm that holds the displays may unintentionally lower while being positioned, which could lead to physical injury for anyone standing beneath the ceiling or wall suspension. This recall affects 333 units of the Agile Max, 24 units of the dRF Max, and 26 units of the Lotus Max distributed nationwide.

Risk

The support arm mechanism can fail to hold its position, causing the display suspension to drop unexpectedly. This poses a risk of impact or crush injuries to patients or medical staff who are positioned under the display during an imaging procedure.

What You Should Do

  1. Identify if your facility uses Siemens Luminos Agile Max (Model 10762472), Luminos dRF Max (Model 10762471), LUMINOS Lotus Max (Model 11574100), or Multitom Rax (Model 10860700).
  2. Check the serial number of your device against the affected list. For the Agile Max, look for serial numbers such as 64144, 61058, 64374, and others listed in the recall notice. For dRF Max, check for numbers like 8320, 8198, and 8334. For Lotus Max, check for numbers like 10251, 10181, and 10278.
  3. Exercise extreme caution when positioning displays and avoid standing directly under the ceiling or wall suspension arms until the equipment has been inspected.
  4. Contact Siemens Medical Solutions USA, Inc. at their Malvern, Pennsylvania headquarters to coordinate an inspection or repair of the support arm mechanism.
  5. Consult with your facility's biomedical engineering department or your healthcare provider to ensure the device is functioning correctly according to manufacturer safety standards.
  6. For additional information or questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Inspection and potential repair of the support arm

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Luminos Agile Max
Model / REF:
10762472
UPC Codes:
04056869009162
Lot Numbers (333):
64144
61058
64374
64413
64433
64048
64460
64385
64036
64013
64448
64451
64445
64057
64205
64326
64055
64051
64262
64288
64338
64061
64131
64314
64399
64034
64443
64105
64019
64309
64325
61231
64032
64170
64088
64457
64478
64104
64244
64449
64316
64111
64280
64239
64241
64420
64412
64136
64273
64112
Product: Luminos dRF Max
Model / REF:
10762471
Lot Numbers:
8320
8198
8334
8474
8183
8322
8613
8244
8660
8436
8095
8371
8378
7805
5664
5615
8150
8130
8300
8093
8468
7791
8479
7136
Product: LUMINOS Lotus Max
Model / REF:
11574100
UPC Codes:
04056869269931
Lot Numbers:
10251
10181
10278
10274
10115
10309
10024
10140
10073
10327
10091
10307
10253
10117
10311
10030
10194
10029
10063
10076
10173
10172
10170
10079
10234
10330
Product: Multitom Rax
Model / REF:
10860700

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94948
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc
Sold By: Siemens Medical Solutions USA, Inc.
Manufactured In: United States
Units Affected: 4 products (333 units; 24 units; 26 units; 0)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.