Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
Class I - DangerousWhat Should You Do?
- Check if you have this product: US1251000031 US1311000006 US1407000009 US1419000044 US1438000118 US1446000275 US1547001419 US1610001769 US1625002302 US1638002539 US1450000330 US1746001254 US1311000077 US1417000003 US1511000589 US1319000051 US1537001287 US1736000931 US1604001618 US1623002140 153 US1251000021 US1203010332 US1604001569 US1407000057 US1324000017 420 421 428 251 616 US1234000045 14 US1537001306 45 US1603001509 US1617002012 US1438000113 US1334000026 US1239000047 US1203010392 US1417000036 1213 US1319000082 US1608001676 US1611001852 US1324000025 US1731000712 US1609001745 US1334000028 US1248000022 US1638002517 US1638002591 US1644002662 US1644002668 US1644002682 US1546001353 US1203010414 US1424000022 US1523000858 US1547001364 US1547001374 US1547001394 US1547001395 US1610001753 US1626002429 US1201010146 US1202010179 US1244000031 US1244000058 US1505000520 US1534001212 US1738001102 US1203010380 US1644002701 US1505000552 US1523000883 US1604001624 US1609001735 US1611001878 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips Electronics North America Corporation
- Reason for Recall:
- There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
Product Codes/Lot Numbers:
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Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0614-2019
Related Recalls
A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the Power On Self-Test. The issue is only apparent when the device is being used in Monitor Mode at an altitude of greater than 4,500 feet.
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Philips Electronics North America
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.