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.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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