Device recall: MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic…

Class II FDA enforcement event 71134. Recall start date: 6 Mar 2015. Status in the FDA record: Terminated. Termination date: 13 Mar 2017.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Philips Medical Systems (Cleveland) Inc started this device recall on 6 Mar 2015. The firm address in the FDA record is in Cleveland, OH. FDA put the recall in Class II. FDA event 71134 has 35 product records. The first FDA enforcement report date is 17 Jun 2015. The record gives the status Terminated, with the termination date 13 Mar 2017.

FDA enforcement report The 35 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria,…

Recalling firm

Philips Medical Systems (Cleveland) Inc, Cleveland, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

35 product records in the event.

FDA event 71134: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1759-2015	MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	125 units	Class II	Terminated	17 Jun 2015
Z-1760-2015	MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	11	Class II	Terminated	17 Jun 2015
Z-1761-2015	Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	788 units	Class II	Terminated	17 Jun 2015
Z-1762-2015	Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	17 units	Class II	Terminated	17 Jun 2015
Z-1763-2015	Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	376 units	Class II	Terminated	17 Jun 2015
Z-1764-2015	Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	126 units	Class II	Terminated	17 Jun 2015
Z-1765-2015	Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	847 units	Class II	Terminated	17 Jun 2015
Z-1766-2015	Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	25 units	Class II	Terminated	17 Jun 2015
Z-1767-2015	Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	1 unit	Class II	Terminated	17 Jun 2015
Z-1768-2015	Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	350 units	Class II	Terminated	17 Jun 2015
Z-1769-2015	iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	110 units	Class II	Terminated	17 Jun 2015
Z-1770-2015	Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	23 units	Class II	Terminated	17 Jun 2015
Z-1771-2015	Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	215 Units	Class II	Terminated	17 Jun 2015
Z-1772-2015	Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	288 units	Class II	Terminated	17 Jun 2015
Z-1773-2015	Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	156 units	Class II	Terminated	17 Jun 2015
Z-1774-2015	FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	10 units	Class II	Terminated	17 Jun 2015
Z-1775-2015	AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	1 unit	Class II	Terminated	17 Jun 2015
Z-1776-2015	Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	7 units	Class II	Terminated	17 Jun 2015
Z-1777-2015	Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	11 units	Class II	Terminated	17 Jun 2015
Z-1778-2015	Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	36 units	Class II	Terminated	17 Jun 2015
Z-1779-2015	Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	1 unit	Class II	Terminated	17 Jun 2015
Z-1780-2015	Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	9 units	Class II	Terminated	17 Jun 2015
Z-1781-2015	Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	15 units	Class II	Terminated	17 Jun 2015
Z-1782-2015	Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	10 units	Class II	Terminated	17 Jun 2015
Z-1783-2015	TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	31 units	Class II	Terminated	17 Jun 2015
Z-1784-2015	CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	81 units	Class II	Terminated	17 Jun 2015
Z-1785-2015	Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	14 units	Class II	Terminated	17 Jun 2015
Z-1786-2015	GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	69 units	Class II	Terminated	17 Jun 2015
Z-1787-2015	GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	71 units	Class II	Terminated	17 Jun 2015
Z-1788-2015	GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	3 units	Class II	Terminated	17 Jun 2015
Z-1789-2015	GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	39 units	Class II	Terminated	17 Jun 2015
Z-1790-2015	BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	108 units	Class II	Terminated	17 Jun 2015
Z-1791-2015	BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	277 units	Class II	Terminated	17 Jun 2015
Z-1792-2015	BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	337	Class II	Terminated	17 Jun 2015
Z-1793-2015	Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.	2 units	Class II	Terminated	17 Jun 2015

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 35Median of the firm: 1
Events of the firm on the register: 129

Other events of the firm

Other FDA enforcement events of Philips Medical Systems (Cleveland) Inc
Initiated	Product (first record)	Type	Class	Records
5 Aug 2025	Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)0088483	Device	Class II	1
17 Jul 2025	Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software	Device	Class II	1
30 Aug 2022	Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.	Device	Class II	1
19 Sep 2019	Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and posit	Device	Class I	5
24 Jun 2019	Ingenuity CT, Model # 728326, computed tomography x-ray system	Device	Class II	9
10 Jun 2019	BrightView SPECT, Model Number 882480	Device	Class II	3
3 Jun 2019	Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) sys	Device	Class II	1
19 Dec 2018	Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Em	Device	Class II	1
18 Oct 2018	Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images	Device	Class II	6
4 Sep 2018	Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnos	Device	Class II	1

Philips Medical Systems (Cleveland) Inc: all 129 events

Official channels

FDA enforcement report Z-1759-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 71134. https://recallregister.com/fda/ii/71134/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria,…
What quantity of product is in FDA event 71134?: The event has 35 product records. The first record gives this quantity: 125 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.