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Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray s...

FDA Device Recall #Z-1771-2015 — Class II — March 6, 2015

Recall Summary

Recall Number Z-1771-2015
Classification Class II — Moderate risk
Date Initiated March 6, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Medical Systems (Cleveland) Inc
Location Cleveland, OH
Product Type Devices
Quantity 215 Units

Product Description

Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Reason for Recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Distribution Pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

Lot / Code Information

Model #: 728321; Serial #s: 52000, 52001, 52002, 52004, 52006, 52007, 52008, 52009, 52010, 52013, 52015, 52016, 52017, 52018, 52020, 52021, 52022, 52024, 52026, 52033, 52038, 52039, 52046, 52051, 52052, 52057, 310001, 310002, 310003, 310004, 310005, 310006, 310007, 310009, 310010, 310011, 310012, 310013, 310014, 310015, 310016, 310017, 310018, 310019, 310020, 310021, 310022, 310024, 310025, 310026, 310027, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310036, 310037, 310038, 310040, 310041, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310056, 310057, 310059, 310060, 310061, 310062, 310063, 310064, 310065, 310066, 310068, 310069, 310070, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 310081, 310082, 310083, 310084, 310085, 310086, 310087, 310088, 310089, 310090, 310091, 310092, 310093, 310094, 310095, 310096, 310097, 310099, 310100, 310101, 310102, 310103, 310104, 310105, 310106, 310107, 310108, 310109, 310110, 310111, 310112, 310113, 310114, 310115, 310116, 310117, 310118, 310119, 310120, 310121, 310123, 310124, 310125, 310126, 310128, 310129, 310131, 310132, 310133, 310134, 310135, 310136, 310137, 310138, 310139, 310140, 310141, 310143, 310144, 310145, 310148, 310149, 310151, 310152, 310153, 310154, 310155, 310157, 310158, 310160, 310161, 310162, 310163, 310164, 310165, 310170, 310171, 333001, 333002, 333003, 333005, 333006, 333007, 333008, 333009, 333010, 333011, 333012, 333013, 333014, 333015, 333016, 333017, 333022, 333024, 333025, 333026, 333027, 333030, 333031, 333035, 333037, 333038, 333042, 333044, 333045, 333046, 333051, 333052, 333053, 333055, 333057, 333060, 333061, 333066.

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Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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