{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150120", "product_res_number": "Z-0080-2017", "event_date_initiated": "2016-09-09", "event_date_posted": "2016-10-13", "recall_status": "Terminated", "event_date_terminated": "2017-08-25", "res_event_number": "75240", "product_code": "EAJ", "product_description": "Zero-Gravity Radiation Protection System\nRadiology\nPersonnel protective shield.", "code_info": "All serial numbers for all models listed below manufactured/distributed between June 28, 2010 August 25, 2016.  Part No. : Description  ZGM-6-.5H : Zero-Gravity floor unit ZGM-6-5ROUNDH : Zero-Gravity floor unit ZGM-6Demo\t : Zero-Gravity demo floor unit ZGCM-48 : Zero-Gravity ceiling mounted monorail with 48 boom arm ZGCM-48-SPECIAL : Zero-Gravity ceiling mounted monorail with 48 boom arm with monorail extension ZG48 : Zero-Gravity 48 boom arm assembly and body shield for monorail ZGCM-66 : Zero-Gravity ceiling mounted monorail with 66 boom arm ZGCM-HSA : Zero-Gravity ceiling mounted monorail with hinged swing arm ZGCH : Zero-Gravity ceiling mounted monorail Contour track with 48 boom arm ZGCH48 : Zero-Gravity 48 boom arm assembly and body shield for Contour track ZGHSA : Zero-Gravity single point, ceiling mount with hinged swing arm ZGCSP : Zero-Gravity single point, ceiling mount with hinged swing arm 29858 : Zero-Gravity floor unit", "firm_fei_number": "1825560", "recalling_firm": "Contour Fabricators Inc", "address_1": "14241 N Fenton Rd", "city": "Fenton", "state": "MI", "postal_code": "48430-1541", "additional_info_contact": "Lisa Huntley\n810-593-3240", "reason_for_recall": "Two customer complaints\nsuggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise)\nwithout allowing the cable to unwind to its normal condition may cause the cable to break\nsuddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the\nZero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body\nshield will fall immediately. A fall of this nature places the user, associated staff and the patient\nat risk for a potential injury.", "root_cause_description": "Labeling design", "action": "On 9/9/2016, URGENT: MEDICAL DEVICE CORRECTION letters dated 9/8/2016 were sent to the affected consignees via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.\n \nTIDI Products is taking the following action to correct this issue:\n1. Revising instructions for use to include the step to allow the cable to unwind after use\nand prior to storing the body shield in a locked or secured position.\n2. Modifying user and staff training protocols to include the requirement to allow the cable\nto unwind after each use.\n3. Adding additional warning labels to the system.\n4. Replacing all cables in the field to ensure that any potentially stressed cable is removed.\n\nA representative from TIDI Products will be contacting you to schedule a visit from a technician\nto implement this corrective action.\n\nCustomer Actions\nCables should be carefully inspected for signs of wear or rotational tension, which will create a\nbend or buckle in the cable. Practitioners and medical institutions should review their routine\nuse of the Zero-Gravity Radiation Protection System to determine if the body shield undergoes\nrepeated rotation without allowing the cable to relax back to its normal condition. If the cable\nhas been consistently rotated in one direction without being allowed to relax back to its normal\ncondition or if there is any doubt about excessive rotation in one direction, TIDI recommends\nthat practitioners and medical institutions discontinue use until such time as corrective action\ncan be implemented by TIDI Products.\n\nIf facilities continue to use their Zero-Gravity\" Radiation Protection System until correction and\ninstall of the replacement cable can be performed, they should make sure that they are allowing\nthe unit to go back to its relaxed state.\n\nPlease complete and return the enclosed response for", "product_quantity": "447", "distribution_pattern": "Nationwide. Canada.\nAUSTRALIA\nAUSTRIA\nBELGIUM\nBRUNEI\nCHINA\nFRANCE\nGERMANY\nINDA\nINDONESIA\nISRAEL\nITALY\nKSA\nMALAYSIA\nNETHERLANDS\nPOLAND\nQATAR\nQUEBEC\nSAUDI ARABIA \nSINGAPORE\nSOUTH AFRICA\nTAIWAN (R.O.C.)", "openfda": { "registration_number": [ "3014680784", "2024351", "3004183518", "3006897996", "3013600135", "1053541", "1225473", "1218386", "3010699203", "2431224", "3044150131", "3017181414", "9680506", "1721686", "3010598169", "3009171220", "3035678069", "2182318", "3026030534", "1219113", "3002532594", "8010704", "1417592", "3005908723", "1222742", "3025001668", "3031564213", "9611503", "3020118", "3031582434" ], "fei_number": [ "2024351", "1000120804", "3004183518", "3006897996", "3013600135", "1053541", "3002808335", "1825560", "3001237319", "1218386", "3010699203", "2431224", "3044150131", "3017181414", "3002807754", "1721686", "3010598169", "3009171220", "3035678069", "2182318", "3026030534", "1219113", "3002532594", "1417592", "3005884106", "3025001668", "3031564213", "3020118", "3031582434", "3002939620" ], "k_number": [ "K832602", "K870563", "K870103", "K832601", "K913621", "K931269" ], "device_name": "Apron, Leaded", "medical_specialty_description": "Radiology", "regulation_number": "892.6500", "device_class": "1" } } ] }