Spacelabs Ultraview SL Command Module Recalled for NIBP Failure
Spacelabs Healthcare is recalling Ultraview SL Command Modules because the Non-Invasive Blood Pressure (NIBP) parameter may become non-functional and display error messages.
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. The hazard involves a medical device failing to provide a critical vital sign (NIBP), which poses a risk of harm to patients, but the source text does not report any specific injuries or fatalities.
Plain-English summary
Spacelabs Healthcare Inc is recalling the 91496 Ultraview SL Command Module, specifically Options A, B, C, and I. The recall affects 3,801 modules and 1,160 PCBAs and valves distributed in the United States, as well as 1,297 modules and 366 PCBAs and valves distributed internationally. The affected units are identified by Manifold Lot Codes 128280, 129420, 129940, or 155640.
The recall was initiated after the firm received multiple reports that the Non-Invasive Blood Pressure (NIBP) parameter became non-functional. When this occurs, the device displays a "No Reading" message along with one of three specific error messages: "Inflate Error," "HW Error," or "No Data."
Healthcare facilities and users should identify affected units by checking the lot codes and contact Spacelabs Healthcare for instructions on corrective actions. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4…
- Manufacturer
- Spacelabs Healthcare Inc
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 (4)
- Manifold Lot Codes: 128280
- 129420
- 129940
- or 155640.
Distribution
Distribution scope not specified by the agency.
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