Philips Recalls Cardiac Workstation 5000 Units for Inaccurate Heart Rate Data
Philips is recalling 796 Cardiac Workstation 5000 units worldwide 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 involves a medical device that provides inaccurate clinical 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 796 units of the Cardiac Workstation 5000 (Product Number: 860439). The recall was initiated 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 locations such as Australia, Canada, and countries across Europe, Asia, and the Middle East. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and users should identify affected units by checking the product number and serial numbers listed in the official recall notice. Users should contact Philips for instructions on how to proceed with the recall and any necessary corrective actions.
The recalled product
- Product
- Cardiac Workstation 5000. Product Number: 860439.
- Manufacturer
- Philips North America Llc
- Hazard
- Affected units
- 796
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: 860439. UDI: (01)00884838094826. Serial Numbers: US42510185
- US42510184
- US52510209
- US52510200
- US52510226
- US52510228
- US62510247
- US62510250
- US62510256
- US72510286
- US82510299
- US82510307
- US82510300
- US82510313
- US82510318
- US82510314
- US82510335
- US82510336
- US82510341
- US82510325
Distribution
Distributed nationwide across the United States.
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