Philips Medical Systems, Inc.
48 recalls on record · Latest: Apr 6, 2016
Philips Medical Systems, Inc. Recall Insight
Philips Medical Systems, Inc. appears on 48 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.057% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 6, 2016, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 48 entries, severity tagging shows 0 critical, 48 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 48 of 48 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (48). The date window on this page runs from Jan 8, 2014 to Apr 6, 2016.
Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended t…
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX…
Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and vas…
Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and va…
Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and va…
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23…
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascu…
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imagi…
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for the termina…
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The Heart…
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. I…
Philips Healthcare DigitalDiagnost System X-Ray
Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter …
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries…
Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
Philips Medical System Allura Xper X-Ray Angiographic
Philips Multi Diagnost Eleva II
Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of the transcutaneous O2 and CO…
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: T…
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System…
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities,…
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on hum…
Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are in…
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrad…
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Ingenia 3.0T, magnetic resonance imaging system.
Ingenia 3.0T R5, magnetic resonance imaging system.
Ingenia 1.5T, magnetic resonance imaging system.
Ingenia 1.5T R5, magnetic resonance imaging system.
Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable Fle…
Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable Fl…
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generat…
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and…
Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrill…
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the terminat…
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical pers…
M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventric…
Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for use for the …
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for use f…
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for …
Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which …
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