Philips Recalls Cardiac Workstation 7000 Due to Inaccurate Heart Rate Data
Philips is recalling 1,810 Cardiac Workstation 7000 units because they may intermittently provide inaccurate native heart rate data.
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 the hazard involves a medical device providing inaccurate data, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips North America LLC is recalling 1,810 units of the Cardiac Workstation 7000 (Product Number: 860441). The recall is being conducted because the device may intermittently provide inaccurate data related to native heart rate.
The affected devices were distributed worldwide, including in the United States and numerous international markets such as Australia, Canada, and countries across Europe and Asia. The recall number is Z-2956-2026.
Healthcare facilities and users should contact Philips North America LLC for instructions on how to address the issue. The source text does not specify a particular corrective action, such as a software update or replacement, but users should follow the manufacturer's guidance to ensure accurate patient monitoring.
The recalled product
- Product
- Cardiac Workstation 7000. Product Number: 860441.
- Manufacturer
- Philips North America Llc
- Hazard
- Affected units
- 1,810
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 (20)
- Product Number: 860441. UDI: (01)00884838094833. Serial Numbers: US22520232
- US32520244
- US32520248
- US42520323
- US42520320
- US42520300
- US52520333
- US52520332
- US52520345
- US52520382
- US52520359
- US52520390
- US52520373
- US52520412
- US52520420
- US52520426
- US52520461
- US62520469
- US62520470
- US62520474
Distribution
Distributed nationwide across the United States.
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