Philips Velara Generator Recall for System Lockup Risk
Philips is recalling 59 Velara Generators with old firmware used with the Integris BH5000 because the system may lock up.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device lockup) where no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is voluntarily recalling 59 Velara Generators that have an old firmware version and are used with the Philips Integris BH5000. The recall was initiated because the system may lock up.
The affected devices were distributed in the United States (AL, CA, DC, IL, GA, KS, MD, MO, NC, NY, OH, PA, RI, SC, TX, WA) and internationally (Brazil, Bulgaria, Costa Rica, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Russian Federation, Singapore, Spain, Sweden, Switzerland, Turkey, United Kingdom). The recall was classified as Class II by the FDA.
Consumers should contact Philips Electronics North America Corporation for further instructions on how to address the firmware issue. The recall was initiated on December 9, 2016, and was terminated on July 30, 2020.
The recalled product
- Product
- Velara Generator with an old Firmware version used with the Philips Integris BH5000
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Generator
- Hazard
- Affected units
- 59
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Velara Generator with 12nc number: 989000070011
- 989000070122
- 989000070123
- 989000070124
- 989000070125
- 989000070126
- 989000070321
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Philips Electronics North America Corporation
See all →- HighPhilips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26
- ModeratePhilips IntelliVue MX40 Patient Monitor Speaker Volume Recall
FDA (Devices) · 2018-12-19
- HighPhilips Medical Monitor Ceiling Suspension Recall for Detachment Risk
FDA (Devices) · 2018-10-03
- HighPhilips Allura Xper FD2O Ceiling Monitor Suspension Recall
FDA (Devices) · 2018-10-03
- HighPhilips AlIura Xper F010 F Monitor Ceiling Suspension Recall
FDA (Devices) · 2018-10-03
Same hazard · system lockup
See all →- HighPhilips Affiniti Ultrasound Systems Recalled for Software Lock-Up During Exams
FDA (Devices) · 2021-09-29
- HighSiemens Sensis Vibe Systems Recalled for Potential System Freezes
FDA (Devices) · 2021-03-10
- HighPhilips Recalls Velara Generators Due to Potential System Lockup
FDA (Devices) · 2017-02-01
- ModerateSiemens ACUSON X700 Ultrasound System Recalled for Software Lockup
FDA (Devices) · 2016-05-04
- ModerateGE Healthcare Recalls Innova IGS 630 Biplane Imaging Systems
FDA (Devices) · 2014-02-05