CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report
BrightView X recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling BrightView X, distributed nationwide in the US. The recall was initiated on 10 Jun 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2010-2019
- FDA event ID
- 83201
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2019
- FDA classified
- 22 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Jun 2019 | Recall initiated by company | |
| 22 Jul 2019 | Classified by FDA | +42 days |
| 31 Jul 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
Product as listed by the FDA
BrightView X , Model Number 882478
Where it was distributed
Worldwide Distribution - US Nationwide
Questions about this recall
Why was it recalled?
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
Which lots are affected?
Serial Numbers: 11000044 11000006 11000033 11000025 11000105 11000016 11000072 11000116 11000101 11000065 11000047 11000018 11000003 11000066 11000078 11000046 11000051 11000114 11000026 11000032 11340001 11000007 11000010 11000027 11000084 11000088 11000057 11000052 11000055 11000068 11000050 11000067 11000070 11000095 11000023 11000102 11000060 11000061 11000094 11000054 11340004 11000091 11000098 11000083 11000063 11000013 11000015 11000062 11000081 11000035 11000009 11000110 11000017 11000090 11000107 11340003 11000056 11000029 11000092 11000041 11000042 11000020 11000109 11000008 11000011 11000039 11000087 11000100 11000093 11000079 11000080 11000074 11000005 11000071 11000043 11000049 11000089 11000030 11000037 11000014 11000104 11000038 11000106 11340002 11000085 11000108 11000040 11000059 11000112 11000045 11000076 11000028 11000113 11000117 11000103 11000069 11000012 11000075 11000004 11000096 11000097 11000048 11000058 11000118 11000086 11000077 11000036 11340005 11000064 11000022 11000031 11000073 11000024 11000019 11000099 11000034 11000115
Where was it sold?
Worldwide Distribution - US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 83201This product is part of a recall event; the main page for the event is BrightView XCT recalled by Philips Medical Systems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | BrightView XCT recalled by Philips Medical Systems | Philips Medical Systems (Cleveland) | Other | Nationwide | |
| CLASS II | BrightView Spect recalled by Philips Medical Systems | Philips Medical Systems (Cleveland) | Other | Nationwide |
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