{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 14 } }, "results": [ { "cfres_id": "192693", "product_res_number": "Z-0967-2022", "event_date_initiated": "2022-02-23", "event_date_posted": "2022-04-21", "recall_status": "Open, Classified", "res_event_number": "89860", "product_code": "OWB", "k_numbers": [ "K181407" ], "product_description": "Artis zee floor, Model Number 10094135", "code_info": "UDI: 4056869010045;\nSerial Numbers: 138481\n137729\n124071\n138390\n135944\n137623\n135111\n135112\n124267\n124253\n137165\n124335\n124338\n124400\n137391\n137714\n124081\n135120\n137282\n135358\n137618\n137226\n135757\n136513\n137103\n137118\n137461\n135102\n136042\n138124\n138132\n135927\n137510\n138260\n138012\n138058\n137193\n135986\n135935\n135953\n138055\n124303\n135841\n138497\n135200\n135201\n135279\n124061\n135879\n135229\n136113\n135990\n138035\n138214\n137479\n138156\n124083\n137532\n137540\n136077\n124102\n137314\n135862\n124116\n135235\n135117\n135920\n137295\n136168\n138087\n137582\n137592\n138221\n138112\n135366\n138084\n137075\n124115\n135843\n138057\n138118\n138061\n135779\n136224\n124395\n137130\n137188\n137131\n137146\n137662\n135137\n138071\n138102\n138486\n136579\n137388\n137470\n124007\n137011\n136280\n138311\n136286\n137347\n135109\n137766\n124384\n138128\n137638\n137731\n124383\n138017\n124394\n137595\n135144\n135145\n136362\n138259\n137245\n137620\n137335\n137607\n137617\n136318\n136234\n138402\n135151\n135421\n135760\n136500\n135217\n137369\n136031\n136032\n137421\n135124\n136084\n137569\n136026\n137425\n136479\n135285\n136338\n136196\n135245\n135420\n124051\n136384\n136387\n136488\n136256\n135767\n136408\n136508\n135182\n137650\n137668\n136242\n136383\n135788\n136517\n135406\n136043\n137311\n137320\n137360\n138163\n135129\n135416\n138004\n135222\n136393\n124268\n137639\n135302\n135260\n137736\n138194\n124273\n138325\n138358\n135143\n137645\n135114\n137093\n136350\n138193\n135253\n135772\n138201\n138250\n135190\n124378\n137591\n137438\n135881\n136614\n136567\n138104\n135714\n137656\n138119\n124302\n138147\n137239\n138005\n136089\n138367\n138397\n135180\n135184\n135922\n124119\n136314\n124703\n137296\n138015\n136190\n136197\n136254\n137458\n138070\n135813\n136970\n137229\n124388\n135791\n137112\n137218\n124080\n138230\n138266\n136561\n138268\n136505\n124006\n137244\n137231\n124118\n135793\n138346\n135132\n135148\n138180\n138480\n137513\n138458\n138513\n139012\n137217\n137224\n135723\n124111\n136126\n136217\n135847\n135281\n135373\n135196\n124344\n136557\n136558\n124286\n137511\n136391\n137297\n135909\n136143\n137403\n139023\n138357\n138381\n135384\n136582\n138340\n136345\n138188\n137567\n136459\n136518\n124314\n136290\n135233\n135353\n136594\n135203\n124056\n137667\n137579\n137551\n138051\n136137\n138190\n135397\n137518\n136278\n\nAdditional Serial Numbers as of 10/4/23: 136450\n135352\n124201\n124089\n136548\n136568\n124015\n136607\n136586\n136555", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "40 Liberty Blvd", "city": "Malvern", "state": "PA", "postal_code": "19355-1418", "additional_info_contact": "Meredith Adams\n610-219-4834", "reason_for_recall": "If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message \"TUBE HOT, have a break\". Several minutes later the system will block X-ray to prevent further damage and display the message \"NO XRAY: TUBE TOO HOT\".", "root_cause_description": "Device Design", "action": "An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 2/23/22 was sent to customers.\n\nWhich steps have to be taken by the user to avoid the possible risks associated with this problem?\nAs also described in the Operator Manual, we recommend that the system operator checks the water level of the cooling circuit at least every three months and refills water, if necessary:\n1. Open the filling gland of the cooling unit. The water surface must be clearly visible above the cooling ribs.\n2. Replenish with water (drinking water quality) if cooling liquid is lacking. Please inform the service technician in case of lacking cooling liquid.\n\nHow will the corrective action be implemented and what is the efficiency of the corrective actions?\nThe tube cooling unit will be equipped with a water level sensor and the software will be updated accordingly. In case the coolant level drops below a certain threshold the following message will be displayed: Tube cooling water level low: Refill as per Operator Manual .\nSiemens will correct the error with a hardware and software update via Update Instruction AX002/20/S and AX004/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.\nWe do not consider it necessary to re-examine any patients in relation to the issues described above. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.\n\nAcknowledge Receipt of this Safety Advisory Notice\nPlease review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein.\nIf you have received this notification by email via Adobe EchoSign, kindly sign with your digital signature to acknowledge that you have read and understand t", "product_quantity": "305 systems", "distribution_pattern": "US Nationwide.", "openfda": { "k_number": [ "K221516", "K243376", "K231669", "K222625", "K040675", "K150967", "K241572", "K210900", "K243328", "K153244", "K123226", "K130893", "K210912", "K152697", "K030544", "K252099", "K160455", "K183109", "K091918", "K172574", "K160147", "K101833", "K052202", "K123508", "K210307", "K936180", "K213479", "K240465", "K190626", "K073543", "K220342", "K243646", "K051064", "K061163", "K234067", "K011292", "K213768", "K010435", "K251523", "K170909", "K230950", "K141979", "K111551", "K232344", "K162614", "K193230", "K111344", "K120282", "K201743", "K041931", "K200022", "K240199", "K251199", "K101868", "K203623", "K220409", "K122644", 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