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Burlington Medical, LLC: Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

Medical DevicesSource: FDA (device) · Date: 2026-04-08

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Burlington Medical, LLC
Product
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
Reason / hazard
Potential for attenuation degradation over time, decreasing the lifespan.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.
Recall initiated
2026-02-11
Code info
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: BATB; UDI-DI (Product Code): 00197513011941 (BATC18-R8BATB-2XF ), 00197513011941 (BATC18-R8BATB-3XF ), 00197513011941 (BATC8-R8BATB-LF ), 00197513011941 (BATC8-R8BATB-LM ), 00197513011941 (BATC8-R8BATB-MF ), 00197513011941 (BATC8-R8BATB-MM ), 00197513011941 (BATC8-R8BATB-PLUS ), 00197513011941 (BATC8-R8BATB-SF ), 00197513011941 (BATC8-R8BATB-XLF ), 00197513011941 (BATC8-R8BATB-XLM ), 00197513011941 (BATC8-R8BATB-XSF ). 2. Model Number: BATH; UDI-DI (Product Code): 00197513011934 (BATC18-R8BATH-2XF ), 00197513011934 (BATC18-R8BATH-2XM ), 00197513011934 (BATC18-R8BATH-3XF ), 00197513011934 (BATC18-R8BATH-3XM ), 00197513011934 (BATC8-R8BATH-LF ), 00197513011934 (BATC8-R8BATH-LM ), 00197513011934 (BATC8-R8BATH-MF ), 00197513011934 (BATC8-R8BATH-MM ), 00197513011934 (BATC8-R8BATH-PLUS ), 00197513011934 (BATC8-R8BATH-SF ), 00197513011934 (BATC8-R8BATH-SM ), 00197513011934 (BATC8-R8BATH-XLF ), 00197513011934 (BATC8-R8BATH-XLM ), 00197513011934 (BATC8-R8BATH-XSF ), 00197513011934 (BATC8-R8BATH-XLF ). 3. Model Number: BATM; UDI-DI (Product Code): 00197513011927 (BATC18-R8BATM-2XF ), 00197513011927 (BATC18-R8BATM-2XM ), 00197513011927 (BATC18-R8BATM-3XF ), 00197513011927 (BATC18-R8BATM-3XM ), 00197513011927 (BATC8-R8BATM-LF ), 00197513011927 (BATC8-R8BATM-LM ), 00197513011927 (BATC8-R8BATM-MF ), 00197513011927 (BATC8-R8BATM-MM ), 00197513011927 (BATC8-R8BATM-PLUS ), 00197513011927 (BATC8-R8BATM-SF ), 00197513011927 (BATC8-R8BATM-SM ), 00197513011927 (BATC8-R8BATM-XLF ), 00197513011927 (BATC8-R8BATM-XLM ), 00197513011927 (BATC8-R8BATM-XSF ), 00197513011927 (BATC8-R8BATM-XSM ).
Product quantity
1,489 units
Voluntary mandated
Voluntary: Firm initiated
City
Newport News
State
VA
Country
United States
Event id
98415
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