Philips Zenition 70 Wireless Foot Switch Firmware Failure Recall
Philips is recalling Zenition 70 wireless foot switches due to a firmware issue that can cause the device to stop responding. This could interrupt imaging procedures if alternative controls are not used.
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: FDA Class II device with a firmware-related control malfunction. Although no injuries have been reported and manual fallback controls are available, the sudden unresponsiveness of a medical device control during procedures presents a risk-of-harm situation, meeting the High severity criterion.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Zenition 70 wireless foot switch, Model #718133, identified by product codes 459801238191 and 459801238231.
The wireless foot switch can suddenly stop responding due to a firmware issue. If the device stops responding and the hand switch or wired foot switch is not available as an alternative, there could be a delay or interruption of the imaging procedure.
Approximately 95 units were distributed domestically across 26 U.S. states, and 284 units were distributed outside the United States.
Facilities that use this equipment should verify whether they have the recalled devices and contact Philips Medical Systems for information on remediation options.
The recalled product
- Product
- Zenition 70, Model #718133
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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 (1)
- Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231
Distribution
Part of a larger recall action
This product is one of 3 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 3 products in this recall →Related recalls
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