Medical device manufacturer
Philips Medical Systems North America Inc.
Philips Medical Systems North America Inc. holds 95 FDA 510(k) clearances across 28 product codes. Median elapsed review time is 63 days. openFDA lists 5 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 95
- Product codes
- 28
- Median review
- 63 days
- Recall records
- 5
How does FDA spell Philips Medical Systems North America Inc.?
FDA publishes this company under 4 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Philips Medical Systems North America Co. | device/510k | normalised |
| Philips Medical Systems North America Inc. | device/recall | normalised |
| Philips Medical Systems North America Inc. | device/enforcement | normalised |
| Philips Medical Systems North America, Inc. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Philips Medical Systems North America Inc. file in?
28 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 19 | 81 days | |
| LLZ | System, Image Processing, Radiological | 16 | 64 days | |
| JAK | System, X-Ray, Tomography, Computed | 10 | 57 days | |
| IZI | System, X-Ray, Angiographic | 9 | 49 days | |
| OWB | Interventional Fluoroscopic X-Ray System | 5 | 25 days | |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 4 | 80 days | |
| KPR | System, X-Ray, Stationary | 4 | 32 days | |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 3 | 44 days | |
| MOS | Coil, Magnetic Resonance, Specialty | 3 | 56 days | |
| IYE | Accelerator, Linear, Medical | 2 | 192 days | |
| IZH | System, X-Ray, Mammographic | 2 | 142 days | |
| IZL | System, X-Ray, Mobile | 2 | 34 days | |
| DQA | Oximeter | 1 | 72 days | |
| DXK | Echocardiograph | 1 | 90 days | |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 146 days | |
| IWE | Monitor, Patient Position, Light-Beam | 1 | 27 days | |
| IXR | Table, Radiographic, Tilting | 1 | 29 days | |
| IZF | System, X-Ray, Tomographic | 1 | 142 days | |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | 72 days | |
| IZP | Programmer, Changer, Film/Cassette, Radiographic | 1 | 169 days | |
| IZW | Collimator, Automatic, Radiographic | 1 | 61 days | |
| KPQ | System, Simulation, Radiation Therapy | 1 | 41 days | |
| KXJ | Table, Radiologic | 1 | 28 days | |
| LMB | Device, Digital Image Storage, Radiological | 1 | 134 days | |
| LMD | System, Digital Image Communications, Radiological | 1 | 39 days |
Showing the 25 they file in most, of 28.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Philips Medical Systems North America Inc. had a recall?
openFDA lists 5 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1263-2014Class IITerminatedIYN
A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by
Z-1264-2014Class IITerminatedIYN
A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated b
Z-1225-2014Class IITerminatedMKJ
Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency.
Z-1232-2014Class IITerminatedMKJ
Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.
Z-0368-2014Class IITerminatedIYN
A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD).
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Philips Medical Systems North America Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K101311 | EP NAVIGATOR R3 | LLZ | 142 | |
| K102005 | ALLURA XPER OR TABLE SERIES | OWB | 25 | |
| K090625 | WIRELESS PORTABLE DETECTOR FD-W17 | MQB | 15 | |
| K090590 | VERADIUS, MODEL 718-130 | OWB | 12 | |
| K082280 | SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR | MHX | 58 | |
| K063781 | PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE | LLZ | 15 | |
| K062233 | HEARTSTART MRX MONITOR/DEFIBRILLATOR | MKJ | 112 | |
| K062268 | MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 | DQA | 72 | |
| K062283 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS | MHX | 44 | |
| K061685 | PULSERA | IZL | 92 |
Source: openFDA device/510k · retrieved
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.