{ "meta": { "disclaimer": "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219326", "product_res_number": "Z-1918-2026", "event_date_initiated": "2026-03-27", "event_date_posted": "2026-04-22", "recall_status": "Open, Classified", "res_event_number": "98644", "product_code": "IZL", "k_numbers": [ "K211423" ], "product_description": "Rover Mobile X-ray System\nModel/Catalog Number: MXU-RV35 and MXU-RV71", "code_info": "Lot Code: Refer to product traceability spreadsheet provided\n\nMXU-RV71 UDI: (01)09357123000051/ Serial Numbers: 334\t397\t399\t408\t423\t425\t459\n\n\nMXU-RV35 UDI: (01)09357123000037/ Serial Numbers: 269\t223\t349\t348\t351\t363\t388\t384\t391\t359\t416\t419\t428\t429\t430\t431\t435\t434\t436\t413\t437\t438\t460\t461\t462", "firm_fei_number": "3012855798", "recalling_firm": "Micro-X Ltd.", "address_1": "Unit 14 6 Mab Eastern Promenade 6 Mab Eastern Promenade", "address_2": "Unit 14", "city": "Tonsley", "country": "Australia", "additional_info_contact": "206-2498764", "reason_for_recall": "X-Ray generator may malfunction resulting in the X-Ray being inoperable.", "root_cause_description": "Component design/selection", "action": "On March 27, 2026, Micro-X issued a Urgent: Medical Device Correction Notification, via E-Mail. Micro-X ask consignees to take the following actions:\n\n\"\tContact your local service representative to arrange replacement of the PCBA with the updated version at the next scheduled visit or Preventative Maintenance. In the interim, customers may continue to use the device.\n\"\tTo minimize the likelihood of system failure, the batteries should not be permitted to fully discharge. Any system errors or abnormal behaviours must be reported to your authorised service provider without delay.\n\"\tIf the product has been further distributed to other facilities, please ensure this notice is immediately shared with them.\n\"\tPlease complete and email the Customer Response Form in Appendix 1 to the Micro-X LTD in Australia: djerkovic@micro-x.com and copy support@micro-x.com Completing this form confirms receipt of this notice, understanding of the issue, and the necessary actions to be taken.", "product_quantity": "32 units", "distribution_pattern": "US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.", "openfda": { "k_number": [ "K953292", "K790512", "K240284", "K911841", "K873982", "K203667", "K211423", "K850678", "K242515", "K931279", "K981466", "K090655", "K955036", "K222951", "K902984", "K082627", "K141885", "K790673", "K063262", "K241996", "K103597", "K780999", "K141539", "K781030", "K253185", "K043062", "K992229", "K781982", 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